The following petition was sent to the FDA in an effort to stop the increasing number of Lasik casualties.  Although many doctors have abided by the regulations set by the FDA, and have had successful surgeries, there are many based on the reported number of casualties who have not.  Actual counts of those casualties are not known due to non-reported cases.  Since the FDA cannot totally enforce what they mandate, why should these doctors be allowed to put people at such high risk.

Petition to the Food and Drug Administration regarding Medical Devices used for Elective Refractive Eye Surgery with Premarket Approvals (PMAs)
If additional information, separate comments or any other modification to this submission is required to comply with the FDA’s procedures, please contact the Petitioner as soon as possible.  We the undersigned hereby petition the FDA to change or cancel a regulation, or to take other action as outlined in the FDA’s published procedures (http://www.fda.gov/opacom/backgrounders/voice.html). The scope of this petition involves ALL lasers and other instruments that currently have FDA PreMarket Approvals (PMAs) for elective refractive eye surgery (excluding those solely used for surgeries considered to be either medically necessary or humanitarian and do Not have PMAs.).
Table of Contents
1.  Statement of grounds
1.1  Examples of Devices included in the Scope of the Petition
1.2  Consistency with FDA’s Goals
1.3  Legal Basis of this Petition
1.4  Additional legal basis of this Petition
2.  Reasons for this Petition
3.  Synopsis of Actions requested for the FDA (See section 3 below for further Details).
3.1  ACTION 1.  Develop a national agenda for the prevention of injuries from elective refractive eye surgery and implement it through coordination of federal efforts across a variety of private and public agencies including the Department of Health and Human Services.  Uniform legislation should be required by law, enacted and enforced in every state to mandate specific minimal safety practices.  Gather better data on the quality of care available.  There are precedents in other areas of medicine.  (http://www.hsph.harvard.edu/qcare/schneider.html).  In the interest of Public Health, insist that the FDA’s PMA approvals and labeling include the requirement that all physicians performing this surgery are either properly trained and equipped to handle every possible complication of refractive eye surgery OR that they refer patients with any complication they are Not properly equipped to treat to another physician who is available to treat all complications at the referring physicians expense.
3.2  ACTION 2.  Collect Information on the cost effectiveness of strategies to reduce injuries caused by non-medically necessary elective Refractive Eye Surgery to better inform public debate on the merits of injury interventions.  Many public health safety issues regarding Refractive Eye Surgery have Not been adequately researched.  Create a comprehensive analysis of spending on the magnitude of the total costs of elective eye surgery injuries, and the effectiveness of prevention efforts.
3.3  ACTION 3.  Conduct a retrospective comprehensive study of the incidence and prevalence of injuries to track ALL the relevant risks.  Gather and collect all surveillance and monitoring data to allow proper education and targeting of interventions.  Could the Medical Device Surveillance Network, MedSuN program be used for this purpose?  The United Sates Eye Injury Registry (USEIR; http://www.useironline.org/Index2.html), a federation of state eye registries, uses a standardized form to obtain voluntarily reported data on eye injuries.
3.4  ACTION 4.  Draft an enforcement policy for implementation of the Federal Food, Drug, and Cosmetic Act regarding these devices along with a document of comprehensive guidance for industry (or update any existing documents to reflect the current state of knowledge). There is a precedence for the FDA providing guidance on other things regulated by the FDA (http://www.fda.gov/OHRMS/DOCKETS/98fr/060702c.htm).
3.5  ACTION 5.  Create national training programs and career development awards for a multidisciplinary group of professionals to monitor and implement elective eye surgery injury controls with funding from federal agencies.
3.6  ACTION 6.  Implement of the final FDA ruling should involve, among other things, package redesign, redesign of websites and promotional literature, and sometimes, new packaging for equipment, and an update of the labeling requirements for all devices for any and all then currently known risks.  Remove any wording that the Public could potentially misinterpret as an endorsement by the FDA including, but not limited to the words Approved, Safe, etc.  The American Society of Cataract and Refractive Surgery (ASCRS) endorses the Lasik Institute as their educational website.  And the Lasik Institute under Suggestions for Further Reading includes links to four consent forms in http://www.lasikinstitute.org/RisksnComplications.html.  Rather than write a consent form based on what the ASCRS believes would be good informed consent, why are these consent forms written by an insurance company (Ophthalmic Mutual Insurance Company)?  
Are these (www.omic.com) ASCRS endorsed informed consent consistent with the labeling requirements of the PMAs for these Class III devices?  
Consent for LASIK for the Correction of Myopia (Nearsightedness).  http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Informed Consent for LASIK for the Correction of Hyperopia (Farsightedness)
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Consent for Bilateral Simultaneous LASIK
http://www.omic.com/resources/risk_man/forms/consent/LASIKbilatsim-myopia.rtf
Consent for LASIK on the Second Eye in an Interval of Less than One Week (myopia)
http://www.omic.com/resources/risk_man/forms/consent/LASIKsecondeye.rtf
“ASCRS Mission: The mission of the American Society of Cataract and Refractive Surgery is to raise the standards and skills of anterior segment surgeons through clinical and practice management education and to work with patients, government and the medical community to promote delivery of quality eye care.”
3.7  ACTION 7.  Oversee the entire life cycle of these devices--from production through distribution, and consumption/use of these class III devices to assess whether the products are as safe as labeled and safe period as stipulated in their PMA approvals.
3.8  ACTION 8.Hold an Ophthalmologic advisory panel meeting to consider the surveillance data for each PMA of all manufacturers and decide whether there is now sufficient data on safety and effectiveness for these class III devices to continue to serve a public health need and whether they should continue to be approved by the FDA.  At what point are the risks of certain types of procedures, equipment or procedures significantly higher such that they should banned?  The Petitioner believe that the potential risks versus possible benefits assessment favor a withdrawal of FDA approval of all PMAs for the lasers listed in this petition in the interest of protecting the Public Health (except for humanitarian purposes only).  
3.9  ACTION 9.  Place a moratorium on any further non-medically necessary elective Refractive Eye Surgeries other than for strict humanitarian purposes If:
the severity, totality of the risks (and their likelihood) of actual injuries to the public that have occurred from the actual practice (including non-research centers) of non-medically necessary elective Refractive Eye Surgeries are a larger risk to the public health than identified in previous research OR
Prudent injury intervention strategies are Not feasible to adequately protect the Public from injury
4.  Certification.  

Statement of grounds
1.1  Examples of Devices included in the Scope of the Petition
Any humanitarian or medically necessary procedures for cataracts or other eye conditions are Not the subject of this petition.
From http://www.fda.gov/cdrh/LASIK/lasers.htm
Company and model
Approval number and date
Approved indications
(D = diopters)
Alcon
- LADARVision
P970043/S10
10/18/02
Wavefront-guided LASIK: Myopia up to -7.0D with or without astigmatism less than 0.5D
Autonomous Technology
- LADARVision
P970043/S5
5/9/00
Myopia less than -9.0D with or without astigmatism from -0.5 to -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027
2/23/00
Myopia from -1.0 to -7.0D with or without astigmatism less than -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027/S2
5/15/02
Myopia less than -11D with or without astigmatism less than -3.0D
Bausch & Lomb Surgical
- Technolas 217a
P990027/S4
2/25/03
Hyperopia between 1.0 and 4.0D with or without astigmatism up to 2.0D
Dishler
P970049
12/16/99
Myopia from -0.5 to -13.0D with or without astigmatism between -0.5 to -4.0D
Kremer
P970005
7/30/98
Myopia from -1.0 to -15.0D with or without astigmatism up to -5.0D
LaserSight
- LaserScan LSX
P980008/S5
9/28/01
Myopia from -0.5 to -6.0D with or without astigmatism up to 4.5D
Nidek
- EC5000
P970053/S2
4/14/00
Myopia from -1.0 to -14.0D with or without astigmatism less than 4.0D
Summit
- Apex Plus
P930034/S13
10/21/99
Myopia less than -14.0D with or without astigmatism from 0.5 to 5.0D
Summit Autonomous
- LADARVision
P970043/S7
9/22/00
Hyperopia less than 6.0D with or without astigmatism less than -6.0D
VISX
- Star S2 & S3
P930016/S12
4/27/01
Hyperopia between +0.5 and +5.0D with or without astigmatism up to +3.0D
VISX
- Star S2 & S3
P930016/S14
11/16/01
Mixed astigmatism up to 6.0D; cylinder is greater than sphere and of opposite sign
VISX
- Star S2
P990010
11/19/99
Myopia less than -14.0D with or without astigmatism between -0.5 and -5.0D
VISX
- Star S3 (EyeTracker)
P990010/S1
4/20/00
Same as S2, except with eye tracker
 
 
 

 

FDA-Approved lasers for PRK and other refractive surgeries
Company and model
Approval number and date
Approved indications
(D = diopters)
Autonomous Technology
- LADARVision
P970043
11/2/98
PRK; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D
Bausch & Lomb Surgical
- KERACOR 116
P970056
9/28/99
PRK; Myopia from -1.5 to -7.0D with or without astigmatism less than -4.5D
LaserSight
- LaserScan LSX
P980008
11/12/99
PRK; Myopia from -1.0 to -6.0D with or without astigmatism less than 1.0D
Nidek
- EC5000
P970053
12/17/98
PRK; Myopia from -0.75 to -13.0D
Nidek
- EC5000
P970053/S1
9/29/99
PRK; Myopia from -1.0 to -8.0D with or without astigmatism from -0.5 to -4.0D
Refractec
- ViewPoint CK System
P010018
4 /11/02
Conductive keratoplasty; Hyperopia from +0.75 to +3.25D with or without astigmatism up to 0.75D
Summit
- Apex & Apex Plus
P930034
10/25/95
PRK; Myopia from -1.5 to -7.0D
Summit
- Apex Plus
P930034/S9
3/11/98
PRK; Myopia from -1.0 to -6.0D with or without astigmatism from -1.0 to -4.0D
Summit
- Apex Plus
P930034/S12
10/21/99
PRK; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D
Summit Autonomous
- LADARVision
P970043/S8
7/11/00
Name Change Only
Sunrise
- Hyperion
P990078
6/30/00
Laser Thermokeratoplasty (LTK); Hyperopia from +0.75 to +2.5D with or without astigmatism less than 0.75D
VISX
- Model B & C (Star & Star S2)
P930016
3/27/96
PRK; Myopia from 0 to -6.0D
VISX
- Model B & C (Star & Star S2)
P930016/S3
4/24/97
PRK; Myopia from 0 to -6.0D with or without astigmatism from -0.75 to -4.0D
VISX
- Model B & C (Star & Star S2)
P930016/S5
1/29/98
PRK; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D
VISX
- Star S2
P930016/S7
11/2/98
PRK; Hyperopia from +1.0 to +6.0D
VISX
- Star S2 & S3
P930016/S10
10/18/00
PRK; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D
VISX
- Star S2 & S3
P930016/S13
3/19/01
Add myopia blend zone; increase overall ablation zone from 6.5 to 8.0mm

 

1.2 Consistency with FDA’s Goals.
The benefits of this petition outweigh the costs by effectively utilizing the limited FDA resources in an area where they are most needed to meet the goals of the FDA, Assuring Medical Product Safety, and protecting the Public Health.  (http://www.fda.gov/ope/FY03plan/default.htm).  The following statements provide the basis for the benefits of this petition.  The costs would be based on which agencies and what specific actions are taken based on this petition.
“Consumers spend $326 billion annually in the U.S. on medical products. An estimated 1.3 million people are accidentally injured by medical therapy in the U.S. each year, and as many as 100,000 die as a result of preventable medical errors. FDA must be vigilant in monitoring the production, distribution and use of these products because FDA's presence raises the likelihood that public health and safety problems associated with these products will be addressed and because it is critical to citizen safety.”
“To ensure that these products are safe the Agency must oversee their entire life cycle--from production through distribution, and consumption/use. “
“FDA's three primary strategies for ensuring medical product safety are to: a) enhance global vigilance over product manufacturing and distribution; b) strengthen and focus domestic industry monitoring; and, c) expand and automate the systems which report on adverse events associated with the use of medical products. “
The FDA’s goals are consistent with preventing injury and protecting the Public Health.  Has the FDA ignored or even endorsed another potential Public Health Crisis (e.g., breast implants)?
“A weakened FDA can only move slowly and with uncertainty. Consumer confidence in the Agency suffers, and real health and safety risks may grow.”
http://www.fda.gov/ope/fy03plan/goals3.html
“*   Human Subject Protection--FDA, in cooperation with other health and safety overseers, must ensure that human subjects are adequately protected during clinical trials. There is heightened concern for the rights and welfare of volunteers, given the rapidly changing research environment has led to a proliferation of multi-site clinical trials, an increase in clinical trials using vulnerable populations. . .“
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=9
“Although FDA does place emphasis on expedited review of new products, it is also responsible for overseeing all of the activities that span new product development--from initial research to final market approval.”
*   New technologies -- FDA must have a state-of-the-art understanding of the new science and technology that fuels these new products—particularly developments in the biotechnology field--so that review decisions on such products can be based on rigorous science-based standards; “
http://www.fda.gov/ope/fy03plan/goals4.html
(http://www.fda.gov/ope/fy03plan/goals2.html)
“Radiological health resources dropped from 400 FTEs in FY 1978 to less than 50 FTEs in FY 2001. We are seeing a resurgence of problems in both the medical and consumer product area.”
“Provide inspection coverage for Class II and Class III foreign medical device manufacturers at 9 percent in FY 2003. (15005.02)”
“FDA's premarket functions support the Department's Prevention Priorities, and the postmarket functions support the Department's Medical Errors/Healthcare Quality Priorities.”
Strategic Goal 1:
Provide the medical community with faster access to important, life-saving and health-enhancing medical devices, while assuring their safety and effectiveness.

Medical devices vary widely in their complexity and their degree of risk or benefits, and do not all need the same degree of regulation.

Strategic Goal 2:
Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.

2) Targeted Inspections-for approval to market high risk devices; inspections triggered by adverse reaction incidents; or product recalls
http://www.fda.gov/ope/fy03plan/part2_med.html

“FDA's Center for Devices and Radiological Health (CDRH) has developed key strategies to more directly promote and protect the public health through the total life cycle of a product. This will allow CDRH to focus regulatory resources on products in a least burdensome way no matter what their stage of development; from concept development to active marketing or modification.”

*   Total Product Life Cycle (TPLC) -- Apply TPLC model in coordination with stakeholders;

*   Meaningful Metrics -- Measure and communicate our impact on the public health; and

*   Knowledge Management -- Manage knowledge to support TPLC in the information age.
“Two key strategic goals have been established for the 21st Century:

*   Provide the medical community with faster access to important,
life-saving and health-enhancing medical devices,
while assuring safety and
effectiveness
.

*   Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.“ (
http://www.fda.gov/ope/fy03plan/goals.html)
1.3 Legal Basis for this Petition
The Petitioner make a public demand that the Food and Drug Administration--the leading U.S. public health regulatory agency--assert its authority and supremacy in protecting the Public Health.
There are multiple legal bases for this petition as the lasers have PMAs that place them within the FDA’s and the CDRH division’s jurisdiction as Class III medical devices.
First, The Petitioner believe that the potential risks versus possible benefits assessment favor the Actions proposed in this petition and are consistent with the FDAs own objectives including Healthy People 2010.  “The PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity announced in January 2000 to eliminate health disparities and improve years and quality of life.” (http://www.fda.gov/OHRMS/DOCKETS/98fr/062502c.pdf).
Second, FDA regulations state that the FDA may require the submission of the adverse safety and effectiveness data, as described in the Class III summary or citation under title 21 Parts 800 to 898, Sec. 807.94, Sec. 807.100, section 515, and other Acts (http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm). Currently all of the adverse events are Not reported to the FDA because the FDA does Not enforce reporting by all distributors and medical providers (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).  Also, adverse events related to the procedure the laser is used for, but Not related to the laser itself are Not necessarily reported.
Third, the Petitioner requested actions that the Federal government develop a comprehensive surveillance plan and initiate other measures to protect the Public from injury and the Public Health in general is based on section 522 (21 U.S.C. 360l).  The CDRH has recorded that the failure of these devices has caused serious adverse health consequences and further research proposed in this petition or planned surveillance will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the Public Health under Sec 522 (a) and (b).
Fourth, Section 522(a) states that “ In General.--The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences” (http://www.fda.gov/cder/guidance/105-115.htm#SEC.%20212).
Fifth, under the FDA’s authority with the Federal Food Drug and Cosmetic Act and all rules and regulations promulgated or annexed therein, including, but not limited to section 515(d) (g), 520(e) (q) and (r), 21 CFR 801.109, 21 CFR 803.5, 21 CFR 803.10, 21 CFR 814.82, 21 CFR 814.84, 21 CFR 814.39, and the FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997, the Petitioner ask the FDA to act and to implement the enclosed Actions.
1.4 Additional Legal Basis of this Petition
The FDA is mandated to assure Medical Product Safety.  “To ensure that these products are safe the Agency must oversee their entire life cycle--from production through distribution, and consumption/use“  (http://www.fda.gov/ope/fy03plan/goals3.html).  Even if these PMA approved lasers were safe in the best of hands used for FDA clinical trials, would the FDA meet it’s goals and objectives if it was allowed to be used significantly LESS safely or highly risky ways by medical practitioners and their independent contracts or “technicians” on thousand or millions of United States citizens?
The FDA does consider petitions (http://www.fda.gov/opacom/backgrounders/voice.html) and comments for the development of future policy (http://www.fda.gov/cder/present/DIA62002/risk_mgmt/sld019.htm) and has authority to change that policy under Title 21 Parts 800 to 898, Sec. 807.94, Sec. 807.100, section 515, and other Acts (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=807.100).
According to the World Medical Association Declaration of Helsinki that the FDA has endorsed, “It is the mission of the physician to safeguard the health of the people. His or her knowledge and conscience are dedicated to the fulfillment of this mission.” The Declaration of Geneva of the World Medical Association binds the physician with the words, “The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act only in the patient's interest when providing medical care which might have the effect of weakening the physical and mental condition of the patient" (http://www.fda.gov/oc/health/helsinki89.html). And finally, “the Purpose of biomedical research involving human subjects must be to improve diagnostic, therapeutic and prophylactic procedures and the understanding of the aetiology and pathogenesis of disease.”
The FDA also supports the The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
Are the Basic Ethical Principles being followed to protect the patient including informed consent,information, comprehension, risk/benefit assessment, and the selection of subjects for research? (http://www.fda.gov/oc/ohrt/irbs/belmont.html; http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm).  Are the risks and complications done for patients, accurate, and complete? (http://www.eyesurgeryeducation.org/RisksnComplications.html)
“Domestic Industry Monitoring -- The law requires that FDA inspect certain biologics, human and animal drug and feed, and medical device manufacturers at least once every 2 years. Although at least 50 percent of statutory establishments should be inspected annually, only 22 percent of human drug, and 13 percent of medical device statutory establishments were inspected in FY 2000. FDA will still fall far short of its statutory inspection requirements given current funding levels.”
(http://www.fda.gov/ope/fy03plan/goals2.html)
“The Agency must allocate a significant proportion of its inspections to high risk situations, such as firms who are producing high risk medical devices, or where the technology is rapidly evolving and must be more closely monitored.”
Based on the percentage of adverse events reported in the trials used to approve the PMAs for the lasers, the simple fact that the number of serious eye injuries caused by non-medically necessary elective eye surgery far exceeds the number and likelihood of serious eye injuries from ALL other causes provides a legal basis for this petition.  “LASIK is currently the most common type of laser eye surgery in the U.S., performed an estimated 1.5 million times each year.” (http://www.lasikinstitute.org/Newsroom_trialsshow.html).
Furthermore, the American Academy of Ophthalmology has supported banning a device (bottle rockets) that since 1995 due to it causing eye injuries similar to those caused by elective refractive eye surgery.  From July 1990 to December 1994, for instance the total number of serious eye injuries from all causes reported to the United States Eye Injury Registry (USEIR) was 4,575 cases (Serious Eye Injuries Associated With Fireworks- United States, 1990-1994 MMWR Vol. 44/No. 24, June 23, 1995, pp. 449-52; Center for Disease Control MMWR journal). On average over that 4 ½ year time period, that amounts to ~1,017 eye injuries per annum. Based on public information that over a million LASIK operations alone are performed every year and the percentage of those operations causing serious eye problems, the number of serious eye injuries per annum of elective eye surgery far exceeds all other causes.
The Petitioner believe that non-medically necessary elective eye surgery has Not been studied well enough to determine whether it is too risky to the Public Health and the true costs of the FDA continuing to approve the use of any lasers or equipment for this purpose.  Several states have prohibited bottle rocket sales, and such bans are supported by the American Academy of Ophthalmology (AAO; Eye Safety and Sports Ophthalmology Committee. Fireworks remain serious health hazard and cause of blindness. San Francisco: American Academy of Ophthalmology, May 1995). Bottle Rockets were banned by the AAO in part because they cause many of the fireworks related serious eye injuries. From 1990-1994, there were 274 fireworks-related serious eye injuries reported to the United States Eye Injury Registry (USEIR) and approximately 160 of those were caused by bottle rockets (58% of the fireworks injuries; Serious Eye Injuries Associated With Fireworks- United States, 1990-1994 MMWR Vol. 44/No. 24, June 23, 1995, pp. 449-52; Center for Disease Control MMWR journal; http://wonder.cdc.gov/wonder/prevguid/m0037986/m0037986.asp).
The FDA has experienced problems before with silicone breast implants (http://www.fda.gov/cdrh/breastimplants/indexbip.html).  Years after the FDA allowed it to proceed, the Institute of Medicine (IOM) completed its independent, unbiased review of all past and ongoing scientific research study of silicone breast implant safety in June 1999 and concluded “First, reoperations and local and perioperative [right after surgery] complications are frequent enough to be a cause for concern and to justify the conclusion that they are the primary safety issue with silicone breast implants. Complications may have risks themselves, such as pain, disfigurement, and serious infection and they may lead to medical and surgical interventions, such as reoperations, that have risks. Second, risks accumulate over the lifetime of the implant, but quantitative data on this point are lacking for modern implants and deficient historically. Third, information concerning the nature and the relative high frequency of local complications and reoperations is an essential element of adequate informed consent for women undergoing breast implantation.” (http://www.fda.gov/cdrh/breastimplants/birisk.html)
Thousands injured is too many.....We are talking about eyes. not warts lasered off of toes.
2.  Reasons for This Petition
The risks of using these PMA approved medical devices referred to in this petition may far outweigh the potential benefits and present a risk to Public Health.  Are the Cumulative Risks Worth the Benefits of Elective Refractive Eye Surgery?  A permanent loss of eyesight, dry eyes, chronic pain, and/or other “complications of LASIK is a high price to pay when glasses and contacts could provide better vision (in most cases) with a much lower risk.  Taken together, the Petitioner believe the actual sum of the risks for the non-medically necessary use of the Class III devices referred to in this petition far outweigh the potential benefits.  
What is the total cost of elective eye surgery both to the individual and to the Public Health at large? You can take each and every one of the risks and costs, isolate them and ask the question, “Does each outcome standing alone tell you how big the risk is”? And the answer is no. That one standing alone will not tell you that. Examining each brick and saying “This brick does not make a wall” ignores the wall. And studies are important and all of these individual pieces of information are important.  But when we want to see the total picture, the whole picture, we have to examine the pieces and put the picture together. For instance, is the cornea ever again quite as strong as a virgin, untouched cornea?
We the Petitioner is simply asking you to look at the entire wall and see the entire picture. What is the total effect on patients quality of life and the ultimate economic costs of any losses? Wouldn’t outcomes research be useful? (Quality of Life and Pharmacoeconomics: An Introduction by Joyce A. Cramer, Bert, Ph.D. Spilker; Lippincott Williams & Wilkins Publishers; 2nd edition, January 1998).  For additional recommendations on research that could be conducted and why, see Appendix B.  
Some of the more specific reasons for this petition include:
Also See Appendices A, B, C for additional risks necessitating further research.
·        Why would any sane person knowingly consent to taking these risks?  Is it ethical to allow anyone who is healthy to even take these risks, and to only take them for cosmetic reasons when glasses work as well or better?
·        Many medical errors and unintentional injuries from elective corneal eye surgeries can be prevented and are costly.  The risks of using these PMA approved medical devices referred to in this petition may far outweigh the potential benefits and present a risk to Public Health.  Many Substantive Risks and the full scope of the risks have Not been Addressed.  
·        Use of the Terms “Safe” and “Approved” in Connection with Elective Refractive Surgery are Not accurate.  The risks and costs have NOT been studied adequately for the FDA to use the word "safe" or "approved" when referring to eye surgery on formerly normal, healthy eyes.
·        Is comanagement as it is practiced commonly with Elective Eye Surgery where the Optometrists frequently don’t consult with the Opthalmologists about complications safe?  The ASCRS endorses the practice- see their informed consent form: http://www.ascrs.org/advocacy/comanageconsent2.doc.  Here’s how one company uses it for “affordability” in the real world, http://www.lasikvisioninstitute.com/html/bg_affordability.html.  Is this right?
·        Further research is needed to know the full extent of the risks of Elective Refractive Eye Surgery.  The clinical studies upon which the were approved did not provide the FDA with information necessary to judge the full scope of risk. Many Substantive Risks and the full scope of the risks have Not been Addressed including Psychiatric and Psychological Effects.  Psychiatry is a branch of medicine and psychiatric variables tell the story of the real effects of complications on people’s lives.  Is a high satisfaction rate equivalent to an improved quality life?  If patients are delighted when RS succeeds, is it not logical to believe that they will be miserable when it fails?  Should patients know they may be “consenting” to the possibility of being miserable for life?  What about the quality of life for those who are Not satisfied?  Subjects experiencing complications from refractive surgery in the original clinical trials should have been questioned as to the effect of complications on their mood, level of cognitive functioning, and other relevant psychological variables. Instead, the clinical trials report only ophthalmic and optometric variables and many of those were left out too.  With millions of people having refractive surgery every year in the US alone, shouldn’t the real risks be clear?  Patients have a right to know that if refractive surgery fails, it is likely that they will become severely depressed or even experience suicidal ideation.  Patients also need to know that if they do experience severe depression and suicidal ideation, treatment with the modern and effective antidepressant drugs may be impossible because they often aggravate another complication- dry eyes.
·        Are there more risks of a bad outcome, problems or complications at “discount” Lasik providers (http://www.canolaservision.com/info/News.htm)? Whereas it is common in other sciences to study such constructs as interrater reliability and the generalizability of clinical interventions across practioners, the extent to which the clinical outcomes presented in the FDA clinical trials for the above mentioned Class III medical devices is unclear. Thus, respected sources of laser surgery carry information report that "We see a lot of problems from the discount places." (By Julia Malone c.2001 Cox News Service http://www.emoryvision.com/ajc3_2001.html). Previous research has shown that glare, halos, starbursts, diplopia and other vision problems (including in ordinary indoor lighting conditions) are more common in other studies done than in those used for the PMA approvals (http://jrs.slackinc.com/vol142s/abs-l.pdf).  
·        No research was submitted to the FDA regarding patterns of comorbidity of complications. Yet, it is well known that certain complications tend to occur together.  Ophthalmology and comanaging optometrist frequently refer to glare, astigmatism, starbursting, and halos under the acronym “GASH”. These patterns of comorbidity has vast implications for FDA labeling and informed consent that have been neither recognized nor appreciated. If the complications of refractive surgery are not independent, but tend to occur together, then patients must be advised that if they experience one complication, for example, they are likely to experience two or more. In general, the more complications experienced by a patient, the more likely it is that he or she will experience depression, suicidal ideation, or one of the syndromes listed above.
·        Often, final vision quality is inferior to pre-surgical vision and night vision is “. . . significantly impaired” (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf)? "The Canadian Medical Association has added laser eye surgery to a list of risk factors for unsafe driving, and recommends doctors test the night vision of patients who may be experiencing visual difficulty following surgery." (Louise Elliott, Canadian Medical Association Says Laser Eye Surgery Can Pose Driving Risk, Canadian Press, 8/27/00) “58 percent failed a night vision test, said ophthalmologist Dr. William Jory of the London Centre for Refractive Surgery in London, England." (Night Blindness Rising in Laser Eye Surgery Patients, London Free Press, 7/17/00).  “Although high contrast visual acuity recovers by 1 year after PRK, low contrast visual acuity and glare deteriorate significantly and do not recover, even after 1 year.” (J Refract Surg. 1996;12:S267-S268.)  
·        Wavefront is Not the answer to the problems.  "These wavefront things are two or three orders of magnitude better than we can get with the lasers, and the healing response and the environmental conditions also influence our surgery results”. . ."Until we control the variables so we can get the standard of error of the laser down to 0.1 D, all these little measurements we do are not very important”. . .”The standard of error in lasers usually averages about 0.5 D at best, he said.” (http://www.aao.org/aao/news/eyenet/archive/05_00/feature2.html)
·        These laser devices with PMAs, contrary to their PMAs, May Not be as safe or substantially equivalent to the legally marketed devices that were or are currently on the U.S. market and DO in fact raise different questions of safety and effectiveness than the predicate device (http://www.fda.gov/cdrh/dsma/pmaman/sec04a.html#P1821_105059).
·        Adverse Events listed in the Approval orders are Not reported in some cases to the FDA.  The following adverse events are frequently Not reported to the FDA: loss of best spectacle corrected visual acuity (based on acuity prior to surgery), worsening of patient complaints such as double vision, sensitivity to bright lights, increased difficulty with night vision, fluctuations in vision, increase in intraocular pressure, corneal haze, secondary surgical intervention, corneal infiltrate or ulcer, corneal epithelial defect, corneal edema, problems associated with the flap, retinal detachment, and retinal vascular accidents.  As a result, both the FDA and the medical professionals charged with the use of these devices listed herein have failed to acknowledge the extent and severity of complications created by these devices, both to patients and to the public. Please see supportive material listed in Appendix B of this petition.
·        The surveillance system already in place (USEIR) for tracking Serious Eye Injuries is Not being utilized to track the injuries resulting from Elective Refractive Eye Surgery and there is No national registry or database where the data can be shared across centers for further research.  
·        True Outcomes and Complication rates of Refractive Eye Surgery are Not being provided to patients when they ask.  The actual outcomes from the standard use of these devices may actually be much higher than those done in the studies evaluated by the FDA to provide the PMAs for these Class III devices.
·        It just makes common sense Not to do something that is Not medically necessary and that may cause “irreversible blindness”, an inability to work, or an inability to read comfortably even if many people like their vision initially.
·        Cutting a flap or doing anything to a healthy cornea is Not good for the eye or for vision.  “The average dioptric difference in the central region is -1.08 D (flattening), and the average dioptric dif-ference in the outer region is +10.20 D (steepening), all induced just by cutting the flap." (http://www.slackinc.com/eye/jrs/vol164/edit.pdf)
·        Elective Refractive Eye Surgery with Lasers may cause early cataracts.  (PRK and LASIK--their potential risk of cataractogenesis: lipid peroxidation changes in the aqueous humor and crystalline lens of rabbits, Wachtlin J, Blasig IE, Schrunder S, Langenbeck K, Hoffmann F., Cornea. 2000 Jan;19(1):75-9; Photorefractive keratectomy and cataract, Costagliola C, Di Giovanni A, Rinaldi M, Scibelli G, Fioretti F., Surv Ophthalmol. 1997 Nov;42 Suppl 1:S133-40; ArF 193 nm excimer laser corneal surgery as a possible risk factor in cataractogenesis, Costagliola C, Balestrieri P, Fioretti F, Frunzio S, Rinaldi M, Scibelli G, Sebastiani A, Rinaldi E., Exp Eye Res. 1994 Apr;58(4):453-7)
·        The full risks and costs of injuries from these Class III devices have NOT been studied adequately for the FDA to use the word "safe" or "approved" when referring to the use of these devices for eye surgery on formerly normal, healthy eyes.  Please see supportive material listed in Appendix B and C of this petition.  Where is the independent research for elective eye surgeries like there was for breast implants?  Has anyone bothered looking at the risks of re-operations? Are the risks higher and the satisfaction rate lower for re-operations?  Do the risks accumulate over the lifetime of the individual or does it stop shortly after surgery?  What is the risk of irreversible blindness, difficulty reading, or difficulty working?  Are patients adequately informed about the actual risks and the likelihood of those risks occurring in the real world (outside of a controlled study submitted to the FDA)?  
·        How likely is LASIK to cause dry eye?  “Dry Eye Syndrome, is the most frequent patient complaint to eye doctors. About 33 million Americans in all groups experience varying degrees of dry eye syndromes."  (http://www.visionworksusa.com/disease.asp?d_num=5; http://www.ohiovalleyeye.com/eyeinfo_blepharitis.html).  "There is a theory that by cutting across the cornea, you cut the corneal nerves, and it decreases the stimulus of the eye, the feedback mechanism from the eye to the brain. Therefore, you have a reduction in the production of tears." Other theories involve goblet cell disruption caused by the suction ring that is placed at the limbus ― a site that boasts a high concentration of goblet cells ― as well as the idea that an alteration of the tear flow has been brought about by LASIK. "My hunch is that it’s probably a combination of those three as opposed to just one specifically.”. . . "Not all patients are affected, but a very high percentage are." (Diane M. Watson, Patient Education, Proactive Approach Crucial When Treating Lasik-Induced Dry Eye, Primary Care Optom. News, 5/00
·        Patients have experienced medical complications from the use of these devices that are devastating from a psychiatric and psychological perspective, including the development of Acute Stress and Posttraumatic Stress Disorder (accompanied by Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major Depression.  Additionally, patients experiencing these syndromes sometimes describe suicidal ideation.  
·        Are there more risks of a bad outcome, problems or complications at the discount places (http://www.canolaservision.com/info/News.htm)?  "We see a lot of problems from the discount places." (By Julia Malone c.2001 Cox News Service; http://www.emoryvision.com/ajc3_2001.html)
·        Vision quality is usually Not as good afterwards as it was before when corrected with glasses or contacts.  “There is not a single laser on the US market today that delivers the appropriate overall energy for the ablations we perform”. “Our data show that the lasers are actually undertreating in the periphery—at 6.0 mm, it is about 25% reduced from its designated calculation—and in doing so, they make the cornea more oblate, rather than preserve its natural prolate shape” (http://www.crstoday.com/02_current/crst0103_11.html). "The problem with all excimer lasers on the market today is twofold.  First, the engineers assumed that the cornea is spherical rather than prolate.  Second, they assumed that their job was to reshape a relatively steep sphere into a relatively flat sphere, rather than to reshape a steep prolate into a flatter prolate.  As a result, excimer lasers actually reshape prolate corneas into what is known as oblate…This shape is actually optically worse than a sphere, because now the peripheral rays are bent even more powerfully than in the periphery of a sphere, causing even more pronounced spherical aberration when the pupil dilates…This problem affects every patient who undergoes an excimer laser procedure to some extent."  (Dr. Jack Holladay, MD, What We Should Really Tell LASIK Patients, Rev. Ophth., 5/99).  "We need to think in detail about corneal optics after refractive surgery because the normal cornea is relatively trouble-free.  The cornea after refractive surgery is not trouble-free.  It frequently has a more aberrated optical performance than its preoperative counterpart.  (Dr. Leo J. Maguire, Keratorefractive Surgery, Success, and the Public Health, Am. J. Ophth., Vol. 117, No. 3, 3/94).  "We are actually ruining the optics of the eye when we perform LASIK," Holladay said. "That's fine when the pupil is small, but as it gets larger, such as in nighttime conditions, this becomes a problem. For the last five years, I have been preaching that we should not be doing this." (http://jordan.fortwayne.com/ns/projects/lasik/lasik5.php).
·        The shape of the eye is permanently changed from concave to convex- it's well documented.  Is the Public informed that eye surgery causes increased higher order aberrations and what happens when the cornea shape changes from the way it evolved (concave) to a more flattened convex shape?  “There is not a single laser on the US market today that delivers the appropriate overall energy for the ablations we perform”. “Our data show that the lasers are actually undertreating in the periphery—at 6.0 mm, it is about 25% reduced from its designated calculation—and in doing so, they make the cornea more oblate, rather than preserve its natural prolate shape” (http://www.crstoday.com/02_current/crst0103_11.html).  “Conventional laser surgery typically treats the central portion of the eye” (http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html).
·        Some eye surgery causes a permanent wound (a flap) that never heals.  Is this safe?  “The most common cause of an incomplete pass is mechanical interference by the lids, speculum, or drapes." (http://jrs.slackinc.com/vol162s/Gim2.pdf).  LASIK has a unique safety issue not present with other refractive surgical procedures, which stems from the structural weakness of the corneal flap and its poor adhesion to the underlying corneal stroma. In some ways it is remarkable that the flap can "reattach" so easily without sutures.”. . .”There is also the problem of accurately realigning the flap and replacing it in the correct location. Flap decentration has been reported. As with flap wrinkling, it will lead to reduced optical quality.” (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf).
·        What happens to the cornea and the eye after Elective Refractive Eye Surgery is Not healthy (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102; http://www.icare4u.com/surgery.htm).  
·        Ecstasia and endothelial problems may be far more common than is being currently reported.  Is it safe to leave 230um after LASIK?  "Eyes were not operated if the anticipated thickness of the cornea after surgery was 230 µm or less. There were no limits to baseline visual acuity,"  (http://jrs.slackinc.com/vol183/pay.pdf).  "LASIK surgery can cause permanent weakening and ectasia of the cornea even in low myopia.  This necessitated the wearing of hard contact lenses or penetrating keratoplasty." (S. Percy Amoils, Iatrogenic Keratectasia Following Myopic Lasik of Between <4 and 7 Dioptres, Am. Soc. Cataract & Refract. Surg. Meeting, Seattle, WA, 4/99).  "we are quite unaware of the actual thickness of flaps when we make them..." (Bob Kronemyer, Predictability of Residual Stromal Thickness Hinges on Precision of Instrumentation, Ocular Surg. News, 1/1/01).  "...some are beginning to believe that the excimer may not be as innocuous to the endothelium as most think.” (Maxine Lipner, First on the Endothelial Cell Block, Eyeworld, 9/00).  Other references include: http://www.journalofrefractivesurgery.com/showAbst.asp?thing=5084
·        Elective Refractive Eye Surgery may cause permanent problems with the epithelial layer.  “Raised epithelium within the visual axis (figure 3) can affect visual quality” (http://www.revoptom.com/body/articles/10_2001/ro257.htm).  “The prevalence of epithelial ingrowth after LASIK varies from 2 to 10%.2,4,5” “and can result in Peripheral Melt of Flap and other problems.” (http://jrs.slackinc.com/vol141/castill.pdf).  “Recurrent corneal erosions are some-what common following PRK or LASIK due to epithelial injury during scraping of the epithelium or formation of the flap. as a larger number of eyes are included” (http://jrs.slackinc.com/vol181/abs.pdf)  “How is the corneal surface affected by LASIK? Fine lines in a lattice pattern are commonly seen and may represent folds in the epithelium or Bowman's layer. They can be demonstrated within the flap after LASIK and so adversely affect visual acuity”  (http://www.ascrs.org/publications/jcrs/editjun02.html; Carpel E.F., Carlson K.H., Shannon S. Fine lattice lines on the corneal surface after laser in situ keratomileusis (LASIK). Am J Ophthalmol 2000; 129:379–380)
·        "The newly formed corneal surface is often irregularly aspheric, probably the cumulative results of imperfect surgery, equipment, and unpredictable healing."  "Central processing of the visual image in the brain is able to pull out the sharp image from the surrounding blurred images.  However, the limit of resolution of such a process is probably not better than 20/40 if the emmetropic corneal area is small.  I think that the asphericity effect is not only due to a variable corneal surface but also due to fluctuations in refractive index in the subepithelial and/or superficial stroma (ie., the little island lenses)." (http://jrs.slackinc.com/vol142/bkrev.pdf).
·        Glare, Halos, Starbursts, diplopia and other vision problems (including in ordinary indoor lighting conditions) are more common in other studies done than in those used for the PMA approvals (http://jrs.slackinc.com/vol142s/abs-l.pdf).  
·        Are proper steps always filed to protect the public health from  microkeratome induced DLK? (http://jrs.slackinc.com/vol162s/Gim2.pdf; http://jrs.slackinc.com/vol173/amb.pdf; ).  “Another serious, but more frequent complication, is inflammation under the flap or Diffuse Lamellar Keratitis (DLK). This is reported nationally as high as 3-10%”.  http://www.arizonalaservision.com/laservisioncorrection/sideeffects.html.  
·        “Incidence of DLK ranges from 3-9% depending on brand of microkeratome used (http://www.moria-surgical.com/publications/fichier/Microkeratome_comparison_Iacobucci.pdf).
·        “Epithelial defect may increase incidence of DLK from 2% to approximately 56%; epidemic DLK usually means something wrong with, eg, sterilizing system or cannulas; stages—clumping of cells (stage 2 entering stage 3; lift flap and irrigate); stage 4 presentation”  “despite intense steroid regimen; central toxic keratopathy; characteristic mud-crack changes in Bowman's membrane and central haze; stroma melts from toxic effects of inflammation; caveat—even if patient looks good on first day, he or she not "out of woods" for DLK.” (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102).
·        Researchers of injury prevention have concluded that “Legislation and regulation are among the most powerful tools to reduce . . . injuries, and most environment and product design changes require legal action. Many existing laws, however, are not fully enforced or have loopholes that limit their effectiveness, and some effective laws have not been adopted in every state“ (Unintentional Injuries in Childhood, VOLUME 10, NUMBER 1 - SPRING/SUMMER 2000; http://www.futureofchildren.org/information3134/information_show.htm?doc_id=78948)
·        The medical care costs for people with chronic diseases account for more than 70% of the nation's total medical care costs.  Calling Elective Refractive Eye Surgery safe is like raising the interstate speed limit to 120 mph so that gunshot victims can get to the hospital faster.  A permanent loss of eyesight, dry eyes, chronic pain (http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299&section=pe_pmc5), and/or other “complications of LASIK is a high price to pay when glasses and contacts could provide better vision (in most cases) with a much lower risk.
·        Patient’s experiencing the complications from use of these devices suffer medical complications that are devastating from a psychiatric and psychological perspective, including the development of Acute Stress and Posttraumatic Stress Disorder (accompanied by Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major Depression. Additionally, patients experiencing these syndromes frequently describe suicidal ideation.
·        Many people are persuaded that if they listen only to impartial advice, research it thoroughly, and spend a lot of money, lasik will be a wonderful experience and be the best thing they ever do. There’s a common belief in the illusion that we can control outcomes through rationality and that doctors can do no harm. If a highly educated person does thorough due diligence, takes the risks they are told about seriously, and chooses their surgeon carefully, and still ends up in a position where they require a procedure approved only for humanitarian reasons, then how can the general public make a truly informed decision?
Current FDA guidelines regarding the use of these devices to inform patients about risk are not being followed.
3.  Actions Requested of the FDA.
Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
The Petitioner is willing to work with the FDA and any other Federal agencies in assisting with further development of the implementation of any injury prevention efforts including, but not limited to the following actions.
3.1    ACTION 1.  Develop a national agenda for the prevention of injuries from elective refractive eye surgery and implement it through coordination of federal efforts across a variety of private and public agencies including the Department of Health and Human Services.  Uniform legislation should be required by law, enacted and enforced in every state to mandate specific minimal safety practices.  Gather better data on the quality of care available.  There are precedents in other areas of medicine.  (http://www.hsph.harvard.edu/qcare/schneider.html).  In the interest of Public Health, insist that the FDA’s PMA approvals and labeling include the requirement that all physicians performing this surgery are either properly trained and equipped to handle every possible complication of refractive eye surgery OR that they refer patients with any complication they are Not properly equipped to treat to another physician who is available to treat all complications at the referring physicians expense.
Without the most advanced equipment available at some of the centers approved to conduct FDA studies, other medical practitioners performing elective refractive surgery cannot reliably identify complications caused by laser eye surgery. Accordingly, comprehensive national research is needed to identify the numbers of people who have experienced complications, so that they can get help.  Patients should be immediately informed of any complications from the procedure regardless of whether the Medical practitioner considers the complications clinically or non-clinically significant at the time. Note that many of these complications can result in further complications and irreversible consequences if Not treated as early as possible.
1. A minimal cornea depth (preferably 300um) Not including other parts of the eye that do not immediately contribute to corneal strength (e.g., the flap created by LASIK) must be left after surgery. “It is important to realize that cutting corneal tissue requires much greater precision and better quality cut surfaces than cutting tissue in other parts of the body.” (http://jrs.slackinc.com/vol183/pay.pdf)
2. Standardized equipment preparation and cleaning procedures should be identified and addressed. For instance, other instruments used with these PMA devices could be evaluated to minimize bacteria and other problems (that can cause DLK or the transmission of diseases between patients such as CJD).
3. Medical providers must be required to follow strict minimal standardized procedures (a cockpit checklist) including giving patients proper instructions (e.g., which specific light they are supposed to look at), and ensuring that any suction devices are properly used (pressurized within the specified tolerance for the human eye and without interference from the eyelids or instruments).
4. Improper use of equipment or procedures, or product malfunctions must be reported to CDRH.  The FDA must enforce penalties that require accurate reporting.
5. Other requirements to be determined by future research.
3.2  ACTION 2.  Collect Information on the cost effectiveness of strategies to reduce injuries caused by non-medically necessary elective Refractive Eye Surgery to better inform public debate on the merits of injury interventions.  Many public health safety issues regarding Refractive Eye Surgery have Not been adequately researched.  Create a comprehensive analysis of spending on the magnitude of the
total costs of elective eye surgery injuries, and the effectiveness of prevention efforts.
The FDA asked for research to include pupil size.  Now that millions of people have already had elective Refractive Eye Surgery, is it time to do some research on how that might effect the results?  http://www.fda.gov/cdrh/ode/2093.html
This document clearly calls for pupil measurement, but Clinical Research (CRS) and other applicants for the Premarket Approvals (PMA) did not control for pupil size (or for dry eyes).  In one study used to approve a PMA, the study was split into two groups.  Group 1 (723 eyes) had 90% follow up at 3 months and 76% at 6 months.  Group 2 (553 eyes) had a much worse follow up (accountability) rate, 57.5 percent at 3 months.  Effectively 43 percent of the data was excluded by splitting the groups and reporting only the better group of follow-up for the PMA.  
This research does Not appear to be independently done.  From July 22-23, 1999 FDA Ophthalmic Devices Panel Meeting, http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3528t1.pdf.  One comment was "clearly one of the frontiers in LASIK is to actually try to improve quality of vision... we aren't there yet with that" (p.55).  "I have a question about visual quality.... Specifically regarding halo, we know that clinically the halo experience after LASIK tends to be more visually significant and affecting the quality of vision than halos that occur naturally in patients without ever having surgery.... the pre op halo comes from asphericity of corneal lens combined optics where post-op comes from this artificial excavation of cornea just like volcano on surface of the cornea, but off sharply at 6 millimeters.  Have you attempted to assess the degree of halo because from my clinical experience those halos that occur after LASIK tend to be more significant".  (p.129).
Many comments were made about flaws in the study being badly presented:  "... and I think that is the concern that the bigger that portion is that we are missing if we are looking for balancing a small negative effect or at least trying to allow the patients to know what the degree of negative effect is, when there is a lot of missing data it is very difficult to assess that. (page 71)".  Another comment was "... the only comment I would have is that my concern is that I don't know what the complication rate truly is lurking out there. (page 104)."  And “of the three physicians who made presentations to the Panel, one of them wasn't included in the PMA cohort and a second actually just made the cut.  So this is a constant source of concern for me..." "Overall the accountability is less than 75% at 3 months and less than 63% at 6 months". "... there is still need for a standardized questionnaire or instrument to be used for the assessment of patient satisfaction following these procedures" (p.82).  "I have strong concerns regarding accepting the study as a whole because of the data set and if the FDA accepts this kind of study where accountability is only 57 percent..... The doctors should be chided for bad science, and if they enroll patients into a study, they should be ethically bound to follow up on these patients" (p.89).  "The loss to follow-up typically should not exceed 10 percent at one year, and I have a great deal of difficulty with an accountability of 50 to 76 percent at 6 months". (p.98)
Part of this agenda should be the adoption of new diagnostic criteria. The Petitioner proposes including Blepharitis, Dry Eye, Anisokeratometropia (Unequal cornea measure of vision) in studies of vision loss involving cornea irregularities and other potential causes of aberrations.  Research should include information concerning the nature and the relative high frequency of cumulative local complications and reoperations and other essential elements of adequate informed consent including making sure that patients understand what loss of best-corrected vision (BCVA) and vision quality really means to them and their quality of life.  
Does this support this research as being independent of any conflicts of interest?  "... we are dealing with a procedure here which has probably been performed on 100, 200, maybe 300 or more thousand Americans and then performed by many people sitting around this table.  So, it is with that that I am sort of coloring my perspective on this PMA" (p. 182).
3.3  ACTION 3.  Conduct a retrospective comprehensive study of the incidence and prevalence of injuries to track ALL the relevant risks.  Gather and collect all surveillance and monitoring data to allow proper education and targeting of interventions.  Could the Medical Device Surveillance Network, MedSuN program be used for this purpose?  The United Sates Eye Injury Registry (USEIR; http://www.useironline.org/Index2.html), a federation of state eye registries, uses a standardized form to obtain voluntarily reported data on eye injuries.
Many public health safety issues have Not been adequately researched. For example: What are the benefits or costs of studying additional positive or negative outcomes such as changes in the quality of life or incidence or prevalence of chronic pain, cancer, apathy, depression, and/or suicidal ideation? What are the differences in risk of dry eyes from different types of surgeries?  
At what point are the risks of certain types of procedures, equipment or procedures significantly higher such that they should banned? What pre-existing physical and mental conditions might increase the risks of elective eye surgery including diabetes, autoimmune or related problems (e.g., Hyperthyroidism and hypothyroidism), other eye problems, depression or anxiety? By how much would improving safety reduce the incidence or prevalence of the risk factors? Are there studies to know how much risk patients are assuming from elective eye surgery (e.g., what are the chances of a loss in the quality of life) including knowing if they have a pre-existing condition that makes them at a higher risk prior to surgery? What is the total effect on patients quality of life and the ultimate economic costs of any losses? Wouldn’t outcomes research be useful? (Quality of Life and Pharmacoeconomics: An Introduction by Joyce A. Cramer, Bert, Ph.D. Spilker; Lippincott Williams & Wilkins Publishers; 2nd edition, January 1998)
The United Sates Eye Injury Registry (USEIR; http://www.useironline.org/Index2.html), a federation of state eye registries, uses a standardized form to obtain voluntarily reported data on eye injuries. A comparably mandatory recording of any elective eye surgery injury along with a standardized coding of each injury should be required for all 50 states. Medical providers and other information system staff should be trained to use these codes for all instances of elective eye surgery injuries.
Now that LASIK has been used long enough to track long term risks, a retrospective comprehensive study of the incidence and prevalence of a number injuries should be conducting to track ALL the risks. For instance, we know have information that elective eye surgery can lead to depression, suicidal ideation and even some actual suicides (first hand witnesses provided on request; http://www.cdc.gov/ncipc/factsheets/suifacts.htm). The age group most likely to have elective eye surgery (over 40 yrs old) are also those most likely to commit suicide (http://www.cdc.gov/ncipc/fact_book/04_Introduction.htm). Possible instruments that could be used to track qualitative vision problems include the VF-14 (see Cataract Patient Outcomes Research Team (PORT) Study, Steinberg, EP) and the RSVP (refractive status and vision profile) to asses Patient outcomes of refractive surgery (http://www.ascrs.org/publications/jcrs/absmay01.html).
How do these risks vary as the stronger the original prescription the more likely (and more of it) that vision quality will be lost? Are patients informed of the likelihood that this elective surgery is ultimately going to trade off vision quality for a reduction of refractive error that can actually hasten the onset of symptoms of presbyopia. How risky is it to fix undesirable outcomes (meaning, poor ablations) and how likely is it to end up getting “fixed”? Other risks such as blindness, reduced visual acuity and vision quality (even in ordinary indoor lighting conditions), corneal stroma problems (scarring, bowmans membrane), visual aberrations (diplopia, higher order aberrations, striae), epithelial problems, pain and chronic pain, dry eyes, rejection of own tissue (restasis is prescribed after elective eye surgery), glare, starbursts, halos, (GASH), discomfort, loss of quality of life, psychological symptoms (suicidal ideation, depression, anxiety and PTSD), effects on the immediate and extended families of those who are not satisfied, additional risks of further medical or surgical interventions, such as reoperations later or perioperative [right after surgery] (additional surgeries can increase risks including chronic pain; http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299&section=pe_pmc5; and elective eye surgeries have resulted in 8 or more surgeries on an eye), corneal transplantation, subcorneal damage, self or foreign tissue rejection (the use of restasis even when no transplants were used), disfigurement, serious infection, other comorbid conditions, and the likelihood of these and other risks occurring independently or in combination.
Are patients with dry eyes excluded as candidates for surgery per the FDA’s new guidance? Why wasn’t dry eye tracked in the original studies used for the PreMarket approvals of the lasers? IT has been well known for many years that dry eye was a serious problem with elective eye surgeries. "The lurking LASIK complication Dry eye after LASIK can be your most serious refractive complication. Understanding and addressing the problem is key to keeping patients happy. . . it has significant implications on patient satisfaction, and, at times, clinical outcomes. Learning about the incidence, etiology, prevention, and treatment of this problem is critical for a successful refractive practice." (http://www.escrs.org/eurotimes/May2001/lurking.asp).
Can elective eye surgery cause progressive keratoconus? “Recent data have suggested that perturbation of the keratocyte apoptosis/mitosis balance could underlie the development of keratoconus in a proportion of patients” (The Wound Healing Response After Laser In Situ Keratomileusis and Photorefractive Keratectomy. Elusive Control of Biological Variability and Effect on Custom Laser Vision Correction; Steven E. Wilson, MD; Rahul R. Mohan, PhD; Jong-Wook Hong, MD; Jong-Soo Lee, MD; Rosan Choi, MD; Rajiv R. Mohan, PhD; Arch Ophthalmol. 2001;119:889-896.)
What are the risks of using UV light from a laser directly on the human eye?
“UV phototoxicity has been implicated in causing or accelerating the progression of several diseases of the eye or its supporting structures, including the eyelids. The following is a partial list of some of the more common diseases involved.· Basal cell and squamous cell carcinoma, melanoma: skin cancer of the eyelids.  Pingueculae, pterygia: conjunctival growths between the eyelids that may encroach on the visual axis and obstruct or distort vision.  UV photokeratitis, snow blindness, arc welder's burn: acute superficial "burn" of the cornea from high-intensity short-term exposure to UV radiation.  Spheroidal degeneration, Labrador keratopathy: loss of corneal clarity from long-term exposure to UV radiation.  Cataracts: opacification of the crystalline lens of the eye.  Eclipse or solar retinopathy: damage to the retina from acute exposure during an eclipse or while gazing directly at the sun.  Macular degeneration: central retinal damage in the part of the retina responsible for the best sight.  Acceleration of the progression of the pigmentary retinopathies (retinitis pigmentosa), iritis (intraocular inflammation) or cystoid macular edema (central fluid accumulation in the retina).” (http://www.eyesite.ca/english/program-and-services/policy-statements-guidelines/UV-radiation-eye.htm).  
Is there an increased risk of cancer?  “A number of studies have been performed and have shown that the 193 nanometer excimer laser is neither mutagenic nor carcinogenic(16,17).” (http://www.vision-institute.com/director/article-elpk.html).  “The International Agency for Research in Cancer (IARC) has concluded that solar radiation, broad spectrum UVR, and UVA, UVB or UVC radiation are all carcinogenic to experimental animals (IARC, 1992). The main tissues of the human body affected are those of the skin and the eye.” (http://www.nrpb.org/publications/documents_of_nrpb/abstracts/absd13-1.htm). We know that UV light does cause melanoma and that UVC light is the most dangerous UV frequency. Excimer lasers deliver high energy UVC light in a localized area. We know that excessive exposure to UVC light causes Acute kerato-conjunctivitis which is an inflammation of the cornea and conjunctiva (http://www-nehc.med.navy.mil/downloads/ih/IHFOM_CH11.pdf), and we know that a similar inflammation occurs after these laser procedures. We also know that Conjunctival malignant melanoma occurs in that same tissue including the epithelium and stroma (http://www.nova.edu/~kimreed/CONJUNTV.html). We also know that the transformation of a normal cell to a cancer cell can be caused by a variety injuries and harmful agents like cigarette smoke or toxic chemicals or radiation including UV and UVC wavelength radiation (http://www.drmcdougall.com/science/cancer.html).
There are indications that Excimer lasers are mutagenic (Gebhard, E., Lang G.K., Tittelbach, H., Rau, D., Naumann, G.O. (Institut fur Humangenetik, Universitat Erlangen-Nurnberg) “Chromosome mutageniticy of a 193 nm Excimer laser” Fortchr Ophthalmol 1990; (3):229-33; Seiler, T., Bende, T., Wincker, K., Wollensak, J. “Side effects in excimer corneal surgery. DNA damage as a result of 193 nm excimer radiation” Graefes Arch Clin Exp Ophthalmol, 1988; 226(3): 273-6; Trentacost, J., Thompson, K., Parrish, R.K., Hajek, A., Berman, M.R., Ganjei, P. “Mutagenic potential of a 193 nm excimer laser on fibroblasts in tissue culture: Ophthalmology; 94(2): 125-9 1987; “Cytotoxicity and mutagenicity of low intensity, 248 and 193 nm excimer laser radiation in mammalian cells.” Cancer Res. 1987 Jan. 15, 47 (2) : 410-3 ; Kochevar, I.E. (Wellman Laboratories, Mass. General Hosp., Boston) “Cytotoxicity and mutagenicity of excimer laser radiation.” Laser Surg. Med 1989; 9(5): 440-5).
Other wavelengths of radiation can be produced and that this secondary (UVB) radiation could also potentially cause cancer (“In situ measurements via a quartz fiber introduced into the eye to the lens surface showed that secondary radiation in the cataractogenic range between 295 and 320 nm is transmitted by the cornea and reaches the lens. The potential adverse effects of this secondary radiation should be considered when applying 193 nm excimer laser radiation to the cornea.”; Muller-Stolzenburg N., Schrunder S., Helfmann, J., Buchwald, H.J., Muller, G.I. “Fluorescence behavior of the cornea with 193 nm excimer laser irradiation.” Fortschr Ophthalmo; 87(6): 653-8 1990).
Should we know the answer to this question before we do this to a million more people? The R of the acronym LASER sounds that much more perilous and dangerous.  Melanoma does occur in the eye and it occurs on a variety of different types of epithelial cells. We also know there is No cure for melanoma at the present time.
3.4    ACTION 4.  Draft an enforcement policy for implementation of the Federal Food, Drug, and Cosmetic Act regarding these devices along with a document of comprehensive guidance for industry (or update any existing documents to reflect the current state of knowledge). There is a precedence for the FDA providing guidance on other things regulated by the FDA (http://www.fda.gov/OHRMS/DOCKETS/98fr/060702c.htm).
3.5  ACTION 5.  Create national training programs and career development awards for a multidisciplinary group of professionals to monitor and implement elective eye surgery injury controls with funding from federal agencies.
3.6  ACTION 6.  Implement of the final FDA ruling should involve, among other things, package redesign, redesign of websites and promotional literature, and sometimes, new packaging for equipment, and an update of the labeling requirements for all devices for any and all then currently known risks.  Remove any wording that the Public could potentially misinterpret as an endorsement by the FDA including, but not limited to the words Approved, Safe, etc.  The American Society of Cataract and Refractive Surgery (ASCRS) endorses the Lasik Institute as their educational website.  And the Lasik Institute under Suggestions for Further Reading includes links to four consent forms in http://www.lasikinstitute.org/RisksnComplications.html.  Rather than write a consent form based on what the ASCRS believes would be good informed consent, why are these consent forms written by an insurance company (Ophthalmic Mutual Insurance Company)?  
Are these (www.omic.com) ASCRS endorsed informed consent consistent with the labeling requirements of the PMAs for these Class III devices?  
Consent for LASIK for the Correction of Myopia (Nearsightedness).  http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Informed Consent for LASIK for the Correction of Hyperopia (Farsightedness)
http://www.omic.com/resources/risk_man/forms/consent/LASIKconsent.rtf
Consent for Bilateral Simultaneous LASIK
http://www.omic.com/resources/risk_man/forms/consent/LASIKbilatsim-myopia.rtf
Consent for LASIK on the Second Eye in an Interval of Less than One Week (myopia)
http://www.omic.com/resources/risk_man/forms/consent/LASIKsecondeye.rtf
“ASCRS Mission: The mission of the American Society of Cataract and Refractive Surgery is to raise the standards and skills of anterior segment surgeons through clinical and practice management education and to work with patients, government and the medical community to promote delivery of quality eye care.”
Can elective eye surgery result in optical disturbances such as monocular double vision which cannot be corrected with spectacles or soft contact lenses, and that in case of such an outcome, rigid gas permeable contact lenses will be their only non-surgical (in fact, their only full stop) means of restoring their pre-operative vision quality even without visible intra-operative or post-operative mishaps?  For a contact-lens-intolerant patient, this information is critically relevant to their ability to assess the risk/reward equation on a truly informed basis.
Do the consent forms indicate the true level of risk?  Include all the individual risks themselves as well as the cumulative risks of multiple problems and comorbid conditions.  For instance, why does the FDA warn only about problems with a correctable condition due to blurry vision when there is a significant risk that ONE or BOTH eyes will be permanently blurred after elective eye surgery even if monovision isn’t the intended outcome? “Many patients cannot get used to having one eye blurred at all times. Therefore, if you are considering monovision with LASIK, make sure you go through a trial period with contact lenses to see if you can tolerate monovision, before having the surgery performed on your eyes. (http://www.fda.gov/cdrh/LASIK/risks.htm)”.
3.7    ACTION 7.  Oversee the entire life cycle of these devices--from production through distribution, and consumption/use of these class III devices to assess whether the products are as safe as labeled and safe period as stipulated in their PMA approvals.
The Petitioner challenges you to review suggestive findings regularly to identify how some modifications to the potential “candidates” might be safer for the Public Health.  Isn’t the first priority to “first do no harm”?
For the Agency to oversee their entire life cycle--from production through distribution, and consumption/use of these class III devices to assess whether the products are as safe as labeled and safe period as stipulated in their PMA approvals.  Along with this after market surveillance process, the Petitioner also ask the FDA to reconsider whether the potential risks versus possible benefits assessment favor this action, whether SSED documents provide a reasonable assurance of safety and effectiveness for the device as labeled based on the nonclinical and clinical studies described in the PMA, and whether the SSED accurately summarizes both the positive and negative aspects of the scientific evidence as required for each PMA (http://www.fda.gov/cdrh/dsma/pmaman/sec03.html#P784_26552). The Petitioner also ask the FDA to consider whether the manufacturers certification that “a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification) (k), and whether all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted and was reasonable based on the available evidence at that time” (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).
3.8    ACTION 8.Hold an Ophthalmologic advisory panel meeting to consider the surveillance data for each PMA of all manufacturers and decide whether there is now sufficient data on safety and effectiveness for these class III devices to continue to serve a public health need and whether they should continue to be approved by the FDA.  At what point are the risks of certain types of procedures, equipment or procedures significantly higher such that they should banned?  The Petitioner believe that the potential risks versus possible benefits assessment favor a withdrawal of FDA approval of all PMAs for the lasers listed in this petition in the interest of protecting the Public Health (except for humanitarian purposes only).  
There is a precedent for this recommendation: “The FDA brings together its General and Plastic Surgery Devices Panel to review all of the safety data from the manufacturers' PMA's. The purpose of the panel is to advise FDA as to what they could tell the public about the safety and effectiveness of the silicone breast implants based on the PMA's. The panel is composed of a broad range of experts, including representatives from the fields of plastic surgery, oncology, epidemiology, internal medicine, immunology, radiology, pathology, gynecology, toxicology, sociology, biomaterials and psychology, as well as industry and consumer groups. The panel hearing rejects the data from Dow Corning, Mentor, McGhan, and Bioplasty, concluding there is not sufficient data about the risks and benefits of the devices. The panel recommends the devices stay on the market temporarily and with limited access. The need for more safety data is stressed.” (http://www.pbs.org/wgbh/pages/frontline/implants/cron.html)
Review each of these class III devices to assess whether the device is EITHER as safe or substantially equivalent to the legally marketed devices that were or are currently on the U.S. market that the manufacturers used for comparison purposes in their 510(k) submissions for their PMA approvals (http://www.fda.gov/cdrh/dsma/pmaman/front.html; http://www.fda.gov/cdrh/dsma/pmaman/Table%20of%20Contents.html#TopOfPage). As part of this surveillance process, the Petitioner also ask the FDA to consider whether the manufacturers certification that “a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (class III certification) (k) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.” Is reasonable based on the available evidence at this time. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=807).  See Appendix B and C for further discussion and consideration of this action.
3.9  ACTION 9.  Place a moratorium on any further non-medically necessary elective Refractive Eye Surgeries other than for strict humanitarian purposes If: the severity, totality of the risks (and their likelihood) of actual injuries to the public that have occurred from the actual practice (including non-research centers) of non-medically necessary elective Refractive Eye Surgeries are a larger risk to the public health than identified in previous research OR Prudent injury intervention strategies are Not feasible to adequately protect the Public from injury
If the severity and/or the risk (likelihood) of the actual injuries to the public that have occurred from the actual practice (including non-research centers) of non-medically necessary elective eye surgeries are a larger risk to the public health than identified in previous research or prudent injury intervention strategies are Not feasible to adequately protect the Public from injury, then the Petitioner request a moratorium on any further non-medically necessary elective eye surgeries other than for strict humanitarian purposes. There is a precedent for this recommendation: “The Food and Drug Administration today called for a moratorium on the use of silicone gel breast implants until new information on their safety can be thoroughly reviewed by an independent advisory panel and the agency can make a final decision in light of the panel's review.” (http://www.fda.gov//bbs/topics/NEWS/NEW00263.html).
4.  Certification
To the best of the Petitioner’ knowledge, the petition includes all information relevant to the petition, favorable or not (see links and references for details).  
Name and Full address of petitioner
PHONE of petitioner here.
Appendix A.
“FDA's adverse event reporting strategies are intended to: develop a comprehensive adverse event reporting capability; analyze problems surfaced by these reports so that appropriate interventions can be designed; and educate both health professionals and patients about problems and solutions associated with appropriate product use. Two examples of strategies designed to develop more complete reporting are the Medical Device Surveillance Network (MeDSuN) System and the HHS Patient Safety Task Force.”  
http://www.fda.gov/ope/fy03plan/goals3.html
How accurate is the adverse event reporting?
Appendix B: Risks of Elective Refractive Eye Surgery.
As is common practice, Is it accurate to tell anyone “you are a good candidate”?  No-one is a good candidate if the risks are unreasonable.  Is a 50% chance of something happening a calculated “risk” or a coin toss?  How many people should take these risks?  “LASIK is currently the most common type of laser eye surgery in the U.S., performed an estimated 1.5 million times each year.” (http://www.lasikinstitute.org/Newsroom_trialsshow.html).
How much is the risk of decrease in his best-corrected visual acuity?  What are the possible mechanisms for this risk?  Retinal damage, optic nerve damage, a combination of both; optical problems related to positive angle kappa, an ablation decentered over the pupil, and early cataract changes induced by Elective Refractive Eye surgery?
What about the risk of causing or increasing cataracts or floaters?  
What about the risk of Dry eyes relative to all LASIK patients?  An “iatrogenic dry eye” . . .” state is a disease of complex etiology where the biophysical and surface chemical factors play a major role. It is not well understood, it is not easy to diagnose, and even harder to manage.  So it was an unpleasant surprise that a considerable number, now estimated as high as 50% of the patients undergone LASIK surgery complained of dry eyes of various severity.”  About 20% of those are Not better in 3 to 6 months.  (http://silver.he.net/~fjholly/lectures.htm).
In one unpublished study, Dry Eye was most associated with Suicidal Ideation after LASIK.  Aren’t ALL patients told to use eye drops after surgery due to the possibility of dry eyes?  Why weren’t patients warned in the past about a “risk” as common as dry eye (Ang R.T., Dartt D.A., Tsubota K. Dry eye after refractive surgery. Curr Opin Ophthalmol 2001; 12:318–322) and why has the FDA only recently added on the FDA’s own website that "Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. Dry eye not only causes discomfort, but can reduce visual quality due to intermittent blurring and other visual symptoms. This condition may be permanent. Intensive drop therapy and use of plugs or other procedures may be required." (http://www.fda.gov/cdrh/LASIK/risks.htm). Dry eyes was recently added to "Know all the risks and procedure limitations" (http://www.fda.gov/cdrh/LASIK/reduce.htm).  Are Nasal hinges superior?  “As a result, it takes longer for nerves to regenerate in corneas with superior-hinged flaps.". . ."This is a good study that persuasively argues the role of hinge position in the occurrence of dry eye after LASIK” (http://www.docguide.com/news/content.nsf/news/8525697700573E1885256D3200456654; Hinge Position In LASIK Flaps Affects Corneal Sensation And Dry Eye.  May issue of Ophthalmology, Eric D. Donnenfeld).
”DR. GRIMMETT: I would recommend including a comment about the one in four rate of dryness, worse or significantly worse, happened in one in four.
CHAIRMAN McCULLEY: Those are both symptoms and signs.
DR. ROSENTHAL: May I just ask, what about in precaution? This issue of dryness--
CHAIRMAN McCULLEY: It's common after LASIK.
DR. ROSENTHAL: In everybody?
CHAIRMAN McCULLEY: Yes.
DR. ROSENTHAL: So what about people who preoperatively have dry eyes?
CHAIRMAN McCULLEY: They're going to be in worse shape.
DR. MACSAI: Treat them.
DR. ROSENTHAL: What?
DR. MACSAI: They should be screened and treated.
DR. ROSENTHAL: Well, I mean, you know, mild dry eyes. I don't know how we've dealt--I mean, I don't think it's relative to this LASIK procedure, but--
CHAIRMAN McCULLEY: It's not, and we're learning more as time goes on. Now we know, so we don't want to ignore it. It's real. And it's probably important from a patient's information and informed consent to be certain that they're aware, because it can lead to sufficient dissatisfaction to seek attorney help.” (
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3598t1c.pdf, p. 203).  
Many people are persuaded that if they listen only to impartial advice, research it thoroughly, and spend a lot of money, lasik will be a wonderful experience and be the best thing they ever do. There’s a common belief in the illusion that we can control outcomes through rationality and that doctors can do no harm. If a highly educated person does thorough due diligence, takes the risks they are told about seriously, and chooses their surgeon carefully, and still ends up in a position where they require a procedure approved only for humanitarian reasons, then how can the general public make a truly informed decision?
Why would any sane person knowingly consent to taking these risks?  
Is it ethical to allow anyone who is healthy to even take these risks, and to only take them for cosmetic reasons when glasses work as well or better?  What other risks are there on top of these listed below:
·        Many medical errors and unintentional injuries from elective corneal eye surgeries can be prevented and are costly.  The risks of using these PMA approved medical devices referred to in this petition may far outweigh the potential benefits and present a risk to Public Health.  Many Substantive Risks and the full scope of the risks have Not been Addressed.  
·        Use of the Terms “Safe” and “Approved” in Connection with Elective Refractive Surgery are Not accurate.  The risks and costs have NOT been studied adequately for the FDA to use the word "safe" or "approved" when referring to eye surgery on formerly normal, healthy eyes.
·        Is comanagement as it is practiced commonly with Elective Eye Surgery where the Optometrists frequently don’t consult with the Opthalmologists about complications safe?  The ASCRS endorses the practice- see their informed consent form: http://www.ascrs.org/advocacy/comanageconsent2.doc.  Here’s how one company uses it for “affordability” in the real world, http://www.lasikvisioninstitute.com/html/bg_affordability.html.  Is this right?
·        Further research is needed to know the full extent of the risks of Elective Refractive Eye Surgery.  The clinical studies upon which the were approved did not provide the FDA with information necessary to judge the full scope of risk. Many Substantive Risks and the full scope of the risks have Not been Addressed including Psychiatric and Psychological Effects.  Psychiatry is a branch of medicine and psychiatric variables tell the story of the real effects of complications on people’s lives.  Is a high satisfaction rate equivalent to an improved quality life?  If patients are delighted when RS succeeds, is it not logical to believe that they will be miserable when it fails?  Should patients know they may be “consenting” to the possibility of being miserable for life?  What about the quality of life for those who are Not satisfied?  Subjects experiencing complications from refractive surgery in the original clinical trials should have been questioned as to the effect of complications on their mood, level of cognitive functioning, and other relevant psychological variables. Instead, the clinical trials report only ophthalmic and optometric variables and many of those were left out too.  With millions of people having refractive surgery every year in the US alone, shouldn’t the real risks be clear?  Patients have a right to know that if refractive surgery fails, it is likely that they will become severely depressed or even experience suicidal ideation.  Patients also need to know that if they do experience severe depression and suicidal ideation, treatment with the modern and effective antidepressant drugs may be impossible because they often aggravate another complication- dry eyes.
·        Are there more risks of a bad outcome, problems or complications at “discount” Lasik providers (http://www.canolaservision.com/info/News.htm)? Whereas it is common in other sciences to study such constructs as interrater reliability and the generalizability of clinical interventions across practioners, the extent to which the clinical outcomes presented in the FDA clinical trials for the above mentioned Class III medical devices is unclear. Thus, respected sources of laser surgery carry information report that "We see a lot of problems from the discount places." (By Julia Malone c.2001 Cox News Service http://www.emoryvision.com/ajc3_2001.html). Previous research has shown that glare, halos, starbursts, diplopia and other vision problems (including in ordinary indoor lighting conditions) are more common in other studies done than in those used for the PMA approvals (http://jrs.slackinc.com/vol142s/abs-l.pdf).  
·        No research was submitted to the FDA regarding patterns of comorbidity of complications. Yet, it is well known that certain complications tend to occur together.  Ophthalmology and comanaging optometrist frequently refer to glare, astigmatism, starbursting, and halos under the acronym “GASH”. These patterns of comorbidity has vast implications for FDA labeling and informed consent that have been neither recognized nor appreciated. If the complications of refractive surgery are not independent, but tend to occur together, then patients must be advised that if they experience one complication, for example, they are likely to experience two or more. In general, the more complications experienced by a patient, the more likely it is that he or she will experience depression, suicidal ideation, or one of the syndromes listed above.
·        Often, final vision quality is inferior to pre-surgical vision and night vision is “. . . significantly impaired” (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf)? "The Canadian Medical Association has added laser eye surgery to a list of risk factors for unsafe driving, and recommends doctors test the night vision of patients who may be experiencing visual difficulty following surgery." (Louise Elliott, Canadian Medical Association Says Laser Eye Surgery Can Pose Driving Risk, Canadian Press, 8/27/00) “58 percent failed a night vision test, said ophthalmologist Dr. William Jory of the London Centre for Refractive Surgery in London, England." (Night Blindness Rising in Laser Eye Surgery Patients, London Free Press, 7/17/00).  “Although high contrast visual acuity recovers by 1 year after PRK, low contrast visual acuity and glare deteriorate significantly and do not recover, even after 1 year.” (J Refract Surg. 1996;12:S267-S268.)  
·        Wavefront is Not the answer to the problems.  "These wavefront things are two or three orders of magnitude better than we can get with the lasers, and the healing response and the environmental conditions also influence our surgery results”. . ."Until we control the variables so we can get the standard of error of the laser down to 0.1 D, all these little measurements we do are not very important”. . .”The standard of error in lasers usually averages about 0.5 D at best, he said.” (http://www.aao.org/aao/news/eyenet/archive/05_00/feature2.html)
·        These laser devices with PMAs, contrary to their PMAs, May Not be as safe or substantially equivalent to the legally marketed devices that were or are currently on the U.S. market and DO in fact raise different questions of safety and effectiveness than the predicate device (http://www.fda.gov/cdrh/dsma/pmaman/sec04a.html#P1821_105059).
·        Adverse Events listed in the Approval orders are Not reported in some cases to the FDA.  The following adverse events are frequently Not reported to the FDA: loss of best spectacle corrected visual acuity (based on acuity prior to surgery), worsening of patient complaints such as double vision, sensitivity to bright lights, increased difficulty with night vision, fluctuations in vision, increase in intraocular pressure, corneal haze, secondary surgical intervention, corneal infiltrate or ulcer, corneal epithelial defect, corneal edema, problems associated with the flap, retinal detachment, and retinal vascular accidents.  As a result, both the FDA and the medical professionals charged with the use of these devices listed herein have failed to acknowledge the extent and severity of complications created by these devices, both to patients and to the public. Please see supportive material listed in Appendix B of this petition.
·        The surveillance system already in place (USEIR) for tracking Serious Eye Injuries is Not being utilized to track the injuries resulting from Elective Refractive Eye Surgery and there is No national registry or database where the data can be shared across centers for further research.  
·        True Outcomes and Complication rates of Refractive Eye Surgery are Not being provided to patients when they ask.  The actual outcomes from the standard use of these devices may actually be much higher than those done in the studies evaluated by the FDA to provide the PMAs for these Class III devices.
·        It just makes common sense Not to do something that is Not medically necessary and that may cause “irreversible blindness”, an inability to work, or an inability to read comfortably even if many people like their vision initially.
·        Cutting a flap or doing anything to a healthy cornea is Not good for the eye or for vision.  “The average dioptric difference in the central region is -1.08 D (flattening), and the average dioptric dif-ference in the outer region is +10.20 D (steepening), all induced just by cutting the flap." (http://www.slackinc.com/eye/jrs/vol164/edit.pdf)
·        Elective Refractive Eye Surgery with Lasers may cause early cataracts.  (PRK and LASIK--their potential risk of cataractogenesis: lipid peroxidation changes in the aqueous humor and crystalline lens of rabbits, Wachtlin J, Blasig IE, Schrunder S, Langenbeck K, Hoffmann F., Cornea. 2000 Jan;19(1):75-9; Photorefractive keratectomy and cataract, Costagliola C, Di Giovanni A, Rinaldi M, Scibelli G, Fioretti F., Surv Ophthalmol. 1997 Nov;42 Suppl 1:S133-40; ArF 193 nm excimer laser corneal surgery as a possible risk factor in cataractogenesis, Costagliola C, Balestrieri P, Fioretti F, Frunzio S, Rinaldi M, Scibelli G, Sebastiani A, Rinaldi E., Exp Eye Res. 1994 Apr;58(4):453-7)
·        The full risks and costs of injuries from these Class III devices have NOT been studied adequately for the FDA to use the word "safe" or "approved" when referring to the use of these devices for eye surgery on formerly normal, healthy eyes.  Please see supportive material listed in Appendix B and C of this petition.  Where is the independent research for elective eye surgeries like there was for breast implants?  Has anyone bothered looking at the risks of re-operations? Are the risks higher and the satisfaction rate lower for re-operations?  Do the risks accumulate over the lifetime of the individual or does it stop shortly after surgery?  What is the risk of irreversible blindness, difficulty reading, or difficulty working?  Are patients adequately informed about the actual risks and the likelihood of those risks occurring in the real world (outside of a controlled study submitted to the FDA)?  
·        How likely is LASIK to cause dry eye?  “Dry Eye Syndrome, is the most frequent patient complaint to eye doctors. About 33 million Americans in all groups experience varying degrees of dry eye syndromes."  (http://www.visionworksusa.com/disease.asp?d_num=5; http://www.ohiovalleyeye.com/eyeinfo_blepharitis.html).  "There is a theory that by cutting across the cornea, you cut the corneal nerves, and it decreases the stimulus of the eye, the feedback mechanism from the eye to the brain. Therefore, you have a reduction in the production of tears." Other theories involve goblet cell disruption caused by the suction ring that is placed at the limbus ― a site that boasts a high concentration of goblet cells ― as well as the idea that an alteration of the tear flow has been brought about by LASIK. "My hunch is that it’s probably a combination of those three as opposed to just one specifically.”. . . "Not all patients are affected, but a very high percentage are." (Diane M. Watson, Patient Education, Proactive Approach Crucial When Treating Lasik-Induced Dry Eye, Primary Care Optom. News, 5/00
·        Patients have experienced medical complications from the use of these devices that are devastating from a psychiatric and psychological perspective, including the development of Acute Stress and Posttraumatic Stress Disorder (accompanied by Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major Depression.  Additionally, patients experiencing these syndromes sometimes describe suicidal ideation.  
·        Are there more risks of a bad outcome, problems or complications at the discount places (http://www.canolaservision.com/info/News.htm)?  "We see a lot of problems from the discount places." (By Julia Malone c.2001 Cox News Service; http://www.emoryvision.com/ajc3_2001.html)
·        Vision quality is usually Not as good afterwards as it was before when corrected with glasses or contacts.  “There is not a single laser on the US market today that delivers the appropriate overall energy for the ablations we perform”. “Our data show that the lasers are actually undertreating in the periphery—at 6.0 mm, it is about 25% reduced from its designated calculation—and in doing so, they make the cornea more oblate, rather than preserve its natural prolate shape” (http://www.crstoday.com/02_current/crst0103_11.html). "The problem with all excimer lasers on the market today is twofold.  First, the engineers assumed that the cornea is spherical rather than prolate.  Second, they assumed that their job was to reshape a relatively steep sphere into a relatively flat sphere, rather than to reshape a steep prolate into a flatter prolate.  As a result, excimer lasers actually reshape prolate corneas into what is known as oblate…This shape is actually optically worse than a sphere, because now the peripheral rays are bent even more powerfully than in the periphery of a sphere, causing even more pronounced spherical aberration when the pupil dilates…This problem affects every patient who undergoes an excimer laser procedure to some extent."  (Dr. Jack Holladay, MD, What We Should Really Tell LASIK Patients, Rev. Ophth., 5/99).  "We need to think in detail about corneal optics after refractive surgery because the normal cornea is relatively trouble-free.  The cornea after refractive surgery is not trouble-free.  It frequently has a more aberrated optical performance than its preoperative counterpart.  (Dr. Leo J. Maguire, Keratorefractive Surgery, Success, and the Public Health, Am. J. Ophth., Vol. 117, No. 3, 3/94).  "We are actually ruining the optics of the eye when we perform LASIK," Holladay said. "That's fine when the pupil is small, but as it gets larger, such as in nighttime conditions, this becomes a problem. For the last five years, I have been preaching that we should not be doing this." (http://jordan.fortwayne.com/ns/projects/lasik/lasik5.php).
·        The shape of the eye is permanently changed from concave to convex- it's well documented.  Is the Public informed that eye surgery causes increased higher order aberrations and what happens when the cornea shape changes from the way it evolved (concave) to a more flattened convex shape?  “There is not a single laser on the US market today that delivers the appropriate overall energy for the ablations we perform”. “Our data show that the lasers are actually undertreating in the periphery—at 6.0 mm, it is about 25% reduced from its designated calculation—and in doing so, they make the cornea more oblate, rather than preserve its natural prolate shape” (http://www.crstoday.com/02_current/crst0103_11.html).  “Conventional laser surgery typically treats the central portion of the eye” (http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html).
·        Some eye surgery causes a permanent wound (a flap) that never heals.  Is this safe?  “The most common cause of an incomplete pass is mechanical interference by the lids, speculum, or drapes." (http://jrs.slackinc.com/vol162s/Gim2.pdf).  LASIK has a unique safety issue not present with other refractive surgical procedures, which stems from the structural weakness of the corneal flap and its poor adhesion to the underlying corneal stroma. In some ways it is remarkable that the flap can "reattach" so easily without sutures.”. . .”There is also the problem of accurately realigning the flap and replacing it in the correct location. Flap decentration has been reported. As with flap wrinkling, it will lead to reduced optical quality.” (http://www.opt.indiana.edu/IndJOpt/download/ijosum00.pdf).
·        What happens to the cornea and the eye after Elective Refractive Eye Surgery is Not healthy (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102; http://www.icare4u.com/surgery.htm).  
·        Ecstasia and endothelial problems may be far more common than is being currently reported.  Is it safe to leave 230um after LASIK?  "Eyes were not operated if the anticipated thickness of the cornea after surgery was 230 µm or less. There were no limits to baseline visual acuity,"  (http://jrs.slackinc.com/vol183/pay.pdf).  "LASIK surgery can cause permanent weakening and ectasia of the cornea even in low myopia.  This necessitated the wearing of hard contact lenses or penetrating keratoplasty." (S. Percy Amoils, Iatrogenic Keratectasia Following Myopic Lasik of Between <4 and 7 Dioptres, Am. Soc. Cataract & Refract. Surg. Meeting, Seattle, WA, 4/99).  "we are quite unaware of the actual thickness of flaps when we make them..." (Bob Kronemyer, Predictability of Residual Stromal Thickness Hinges on Precision of Instrumentation, Ocular Surg. News, 1/1/01).  "...some are beginning to believe that the excimer may not be as innocuous to the endothelium as most think.” (Maxine Lipner, First on the Endothelial Cell Block, Eyeworld, 9/00).  Other references include: http://www.journalofrefractivesurgery.com/showAbst.asp?thing=5084
·        Elective Refractive Eye Surgery may cause permanent problems with the epithelial layer.  “Raised epithelium within the visual axis (figure 3) can affect visual quality” (http://www.revoptom.com/body/articles/10_2001/ro257.htm).  “The prevalence of epithelial ingrowth after LASIK varies from 2 to 10%.2,4,5” “and can result in Peripheral Melt of Flap and other problems.” (http://jrs.slackinc.com/vol141/castill.pdf).  “Recurrent corneal erosions are some-what common following PRK or LASIK due to epithelial injury during scraping of the epithelium or formation of the flap. as a larger number of eyes are included” (http://jrs.slackinc.com/vol181/abs.pdf)  “How is the corneal surface affected by LASIK? Fine lines in a lattice pattern are commonly seen and may represent folds in the epithelium or Bowman's layer. They can be demonstrated within the flap after LASIK and so adversely affect visual acuity”  (http://www.ascrs.org/publications/jcrs/editjun02.html; Carpel E.F., Carlson K.H., Shannon S. Fine lattice lines on the corneal surface after laser in situ keratomileusis (LASIK). Am J Ophthalmol 2000; 129:379–380)
·        "The newly formed corneal surface is often irregularly aspheric, probably the cumulative results of imperfect surgery, equipment, and unpredictable healing."  "Central processing of the visual image in the brain is able to pull out the sharp image from the surrounding blurred images.  However, the limit of resolution of such a process is probably not better than 20/40 if the emmetropic corneal area is small.  I think that the asphericity effect is not only due to a variable corneal surface but also due to fluctuations in refractive index in the subepithelial and/or superficial stroma (ie., the little island lenses)." (http://jrs.slackinc.com/vol142/bkrev.pdf).
·        Glare, Halos, Starbursts, diplopia and other vision problems (including in ordinary indoor lighting conditions) are more common in other studies done than in those used for the PMA approvals (http://jrs.slackinc.com/vol142s/abs-l.pdf).  
·        Are proper steps always filed to protect the public health from  microkeratome induced DLK? (http://jrs.slackinc.com/vol162s/Gim2.pdf; http://jrs.slackinc.com/vol173/amb.pdf; ).  “Another serious, but more frequent complication, is inflammation under the flap or Diffuse Lamellar Keratitis (DLK). This is reported nationally as high as 3-10%”.  http://www.arizonalaservision.com/laservisioncorrection/sideeffects.html.  
·        “Incidence of DLK ranges from 3-9% depending on brand of microkeratome used (http://www.moria-surgical.com/publications/fichier/Microkeratome_comparison_Iacobucci.pdf).
·        “Epithelial defect may increase incidence of DLK from 2% to approximately 56%; epidemic DLK usually means something wrong with, eg, sterilizing system or cannulas; stages—clumping of cells (stage 2 entering stage 3; lift flap and irrigate); stage 4 presentation”  “despite intense steroid regimen; central toxic keratopathy; characteristic mud-crack changes in Bowman's membrane and central haze; stroma melts from toxic effects of inflammation; caveat—even if patient looks good on first day, he or she not "out of woods" for DLK.” (http://www.audio-digest.org/pages/htmlos/0244.35.3746433717410210490/OP4102).
·        Researchers of injury prevention have concluded that “Legislation and regulation are among the most powerful tools to reduce . . . injuries, and most environment and product design changes require legal action. Many existing laws, however, are not fully enforced or have loopholes that limit their effectiveness, and some effective laws have not been adopted in every state“ (Unintentional Injuries in Childhood, VOLUME 10, NUMBER 1 - SPRING/SUMMER 2000; http://www.futureofchildren.org/information3134/information_show.htm?doc_id=78948)
·        The medical care costs for people with chronic diseases account for more than 70% of the nation's total medical care costs.  Calling Elective Refractive Eye Surgery safe is like raising the interstate speed limit to 120 mph so that gunshot victims can get to the hospital faster.  A permanent loss of eyesight, dry eyes, chronic pain (http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6299&section=pe_pmc5), and/or other “complications of LASIK is a high price to pay when glasses and contacts could provide better vision (in most cases) with a much lower risk.
·        Patient’s experiencing the complications from use of these devices suffer medical complications that are devastating from a psychiatric and psychological perspective, including the development of Acute Stress and Posttraumatic Stress Disorder (accompanied by Dissociative symptoms), Generalized Anxiety Disorder, Panic Disorder, Obsessive-Compulsive Disorder, various Adjustment Disorders, and Major Depression. Additionally, patients experiencing these syndromes frequently describe suicidal ideation.
Appendix C.  Informed Consent
Ethically, should anyone even be allowed to consent to taking a risk of seriously damaging their physical and mental health for life?  Are patients informed prior to surgery that a second procedure is typically done months AFTER the eye has healed and there are specific risks incurred in a second surgery so they can include that in their initial decision to have it?
We believe in ethics, we believe in integrity and we believe in justice being done. If you can do that, as I know you will, you will have done your task, and to all of them who suffer and to all of them who might be saved from suffering; and most importantly, perhaps, to yourselves and to those who will follow you. Please do the right thing. Please do not let this opportunity pass you by.
In a very real sense, reading the FDA transcripts prior to the Premarket Approvals (PMAs) of these lasers for unnecessary medical procedures, we have a glimpse of the Ophthalmology University.  It is a fervor that dismisses and rejects all evidence that is not supportive of it. No one said we were going to have all the evidence going one way. The evidence there is has been dismissed poorly studied so let's consider science and research today. Time out. Wait a second. You’re Not doing this stuff to people's bodies without testing all four tires and everything else about the automobile first are you?
You may disagree with us, which is your right. You may say it’s safe enough, but you decide that when this is finished you know two or three things. You have fully considered what has been done before. And you have rendered a decision that makes it real clear that people are not to be treated as cattle or misled. Their damages are not to be limited to their physical losses. Rather they are to include the pain, the mental anguish, economic losses, and the loss of the enjoyment of their life. There's more to life than working. There's more to life than going to the doctor and paying doctor bills. Let us Not forget about all those individuals whose fine, fine life was ruined by this or all those who will be ruined if this is allowed to continue the way it is practiced now.
Just one of the other bricks of this wall of suffering and increase risk of future injuries includes the risk of falls and hip fractures. In 1994, the estimated cost of fall-related injuries alone was $20.2 billion. Older adults’ low light vision decreases by 30% by 60 on average anyway as people age (http://www.universityhospital.org/geriatric_education/sensory.html). What about the potential increase in hip fractures in the elderly when the vision problems caused by elective eye surgery are combined with the degradation of vision that occurs naturally? Many hip fractures are due to vision or balance problems, and “Of all fall-related fractures, hip fractures cause the greatest number of deaths and lead to the most severe health problems and reduced quality of life (Wolinsky 1997; Hall 2000)” (http://www.cdc.gov/ncipc/factsheets/falls.htm). If elective eye surgery increases the rate of falls (a major risk in and of itself given that 300,000 older adults suffer fall-related hip fractures some of which result in death) by even 1%, then there’s an additional cost of over $200 million to the public. How much of the wall of increased risks include the permanent weakening of the cornea (the flap never heals fully), changes in lifestyles, increasing the risks of falls and driving accidents (http://www.biopticdriving.org/DKelleher.htm; do you want to share the road with large numbers of people who have additional iatrogenically induced night driving problems; http://www.icare4u.com/surgery.htm), mental health problems (including the fear of surgery and pain; http://www.partnersagainstpain.com/html/profed/pmc/pe_pmc5.htm?pg=6152&section=pe_pmc5), and other “unknown” long term effects of a permanently wounded cornea caused by it?
Examining another brick in the wall, what about the total cost of chronic pain resulting from this surgery? Trauma and postoperative pain are commonly studied by the government (http://grants1.nih.gov/grants/guide/pa-files/PA-01-115.html). One of the FDA’s main objectives is HEALTHY PEOPLE 2010 (http://www.fda.gov/OHRMS/DOCKETS/98fr/062502c.pdf) which includes managing chronic pain. “The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), The Management of Chronic Pain, is related to one or more of the priority areas.” (http://www.health.gov/healthypeople/). “The prevalence of pain and inadequate pain relief is common. Surveys show that approximately 34 million adults suffer from some form of chronic pain” (http://www.nidr.nih.gov/news/analgesicDevWorkshop.htm). “. . . one in every five Americans reports suffering from some form of chronic pain, and seven in 10 say it interferes with their daily lives.” (http://www.aascif.org/public/archive/summer02/3.2.5_summer02.htm). “Chronic pain disables more people than cancer or heart disease and costs more than both combined. It is estimated that five million Americans are partially disabled by back problems, and two million are so severely disabled that they cannot work. For many people with such chronic conditions as back pain and arthritis, the pain from the condition may interfere with the quality of their lives more than the actual disease or injury.”. . . “With an estimated cost exceeding $125 billion annually in health care, disability compensation, lost productivity, and lost tax revenue.” (http://www.upress.state.ms.us/catalog/spring2002/understanding_chronic_pain.html). A common estimate is that $95 billion is lost annually due to sick time, reduced productivity, and direct medical and other benefit costs (Not including direct costs to the government such as lost tax revenues and disability costs). How much does the chronic pain induced by these elective surgeries add to the cost for the Public Health? Has anyone bothered to ask?
Why are some people so upset that they have suicidal ideation (58 and counting) after elective eye surgery? “About 3,000 patients a year experience an off-center treatment, or asymmetrical healing, which the Custom-CAP is designed to treat.” (http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html) And the FDA considers this a “humanitarian” treatment with unknown effectiveness (zzzzzzzzz Is there a connection that can be made between Tinnitus and elective eye surgery? Like many elective eye surgery patients, “tinnitus patients often are advised to ‘learn to live with it.’ (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10407886&dopt=Abstract). Both result in depression (http://www.ata.org/about_ata/contact.html; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?). Both are chronic, largely untreatable conditions that cause distress leading to increased medical and indirect costs (http://www.flinders.edu.au/research/Reports/1997/SSPsy97.html). Much more of the brain is involved in processing vision than hearing. What would it be like to have something that is constantly annoying and in many cases constantly, chronically painful ALL the time? Thousand or millions of people know the answer to that question well. Why isn’t there any psychosocial treatment offered to assist patients in the identification of aggravating factors and teaching them various coping skills (if possible)? Are the complications of elective eye surgery treated regularly or ignored even when the patient pays for the best medical care possible to get (from centers conducting FDA studies even)?
What about the unknown scientific certainty whether or Not it transmits or causes diseases like cancer or CJD?  We cannot justify performing experiments on millions of people and just waiting to see what happens! We can't implant a TV screen in the eyes of these people and actually trace the cells in their damaged corneas. There is so much that is beyond our control. All of us have said at one time or another or we've seen something on TV or we've read something in the newspaper when we've said, "I just wish I could do something about that," whether it's crime, drugs, a problem at school or a problem with disease. There's so much that we have no control over. But you right now have an opportunity that comes to very, very few of us in a lifetime. You have an opportunity now to make a difference. You have an opportunity to sift through the evidence, to gather new evidence and to carefully weight the consequences of either leaving the wall, rebuilding the wall, or tearing it down entirely.
Stop this scientifically and professionally unjustifiable practice of telling patients that because their corneas “look fine” and they can see the 20/20 or 20/30 line on the chart that they should be happy with their outcome. Does those who practice Ophthalmology honestly believe Snellen acuity is the beginning and the end of the vision equation? Isn’t it well known that there can be a huge amount of spherical aberrations with 20/20 central acuity? Why aren’t statistics kept for all intra-operative complications, post-operative complications, low light uncorrected and best-corrected refractive outcomes, and other induced undesirable optical phenomena? The Petitioner challenge you to gather this data and present it to the FDA Ophthalmic panel and to the laser manufacturers. Does the public have a right to demand that they respond to these questions and concerns?
If science today has proven this product to be safe -- if the science proves this product was so safe, then those hired by the FDA to help the FDA come up with the answer would have given a thumbs up instead of hemming that the long term risks are unknown. We know now that the FDA has also given approval (http://www.fda.gov/cdrh/ode/annrp299.pdf) for humanitarian treatment of up to 4,000 people known to be seriously injured by it. The Custom-CAP was approved by the FDA under a special "Humanitarian Use Device" exemption and is designed to treat the “about 3,000 patients a year [who] experience an off-center treatment” and can result in “It can result in worsened vision, corneal scarring, corneal irregularities or corneal thinning. Moreover, its long-term impacts are not known” (http://www.stanfordhospital.com/newsEvents/newsReleases/2002/052002/correctVision.html). Humanitarian Devices Exemption (HDE) applications are similar in both form and content to PMAs but are exempt from the effectiveness requirements of PMAs (http://www.fda.gov/cdrh/ode/annrp299.pdf). Do we know the true effectiveness and safety of conventional LASIK and other eye surgeries?
Is eye tracking as good as it is supposed to be? “Eye tracking improves accuracy, but still has limitations. Current systems cannot compensate for eye movements exceeding 10°, a physicist said” (http://www.pconsupersite.com/default.asp?ID=5619).  “The eye tracker pauses treatment when an eye movement >0.2 mm occurs between two sampled positions, or when it detects significant non-circularity of the pupil.  The operator can turn the tracker on or off at any time.  The delay between the tracker acquisition of a positional signal and the beam positional response is about 67 msec, less than the interpulse interval of the laser beam.” (http://www.fda.gov/cdrh/pdf/H000002b.doc)
Regarding LASIK, it is well known that most of the “complications” and risks are due to problems with the flap. If LASIK is even .1% less safe (and the real figures may be as much as 50 times that number) than other elective eye surgeries and one million surgeries are done per year, then what do we tell the extra thousand people and their families who are injured by LASIK- potentially for life? Even a nominal increase in safety will effect thousands of people and thousands more of their families, and the public. Let’s determine the impact of legislation, litigation, and regulation in preventing injuries to our shared community and many of those we know and hold dear to us, as well as a very serious danger to our great Nations Public Health in general.
Wouldn’t we want to answer these questions thoroughly before concluding that “PRK and LASIK are safe, effective, and permanent cures for certain vision problems” and “A LOW-RISK ALTERNATIVE TO GLASSES”? (http://www.casad.org/English113/example%20Fall_2000.htm).  
How was this impenetrable wall of horror and suffering created in the first place?  Has anyone asked simply what is going on here?  For many, they are Not so severely effected that the result is acceptable to them, but for a significant minority they simply have to make do with their vision whatever it is. After you know that there is no real way to get help safely and that there are real risks of irreversible blindness, not being able to read, not being able to work, etc., what would you do next?  What if it was you?
Thank you very much.
Appendix E.  What makes you a “good candidate” for elective Refractive Eye Surgery?
According to the FDA,
“You may be a good candidate for laser eye surgery if you:”  
“have a way to pay for the treatment since laser procedures are costly and probably not covered by health insurance policies
are fully informed about the risks and benefits of laser surgery compared with other available treatments.”
(http://www.fda.gov/fdac/features/1998/498_eye.html)
What does the cost have to do with whether or Not a permanently vision threatening procedure is done on healthy eyes?
What are the advantages of doing surgeries known to have less predictable results on vision, worse complications and poorer effects on vision quality?  Isn’t RK Not done anymore because it weakens the cornea?  Does the AAO care about the medical advantages of one eye surgery over another?
According to the American Academy of Ophthalmology (copied 6/24/2003),
http://www.aao.org/vp/edu/refractdemo/v1m1/incisional.cfm
“However, RK has some distinct advantages over modern forms of refractive surgery, including”
“incisions that do not directly involve the optical zone”
“more long-term data on this procedure than on other refractive surgical options”
“equipment that is less expensive than that used in laser surgery”
Given the long-term data that’s available on these incisions and how they do effect the optics, and as all the long-term data indicates that RK damages the structural integrity of the eye, then that only leaves the third reason.  RK is less expensive and is Not widely used any longer except “Surgeons in communities that do not have access to laser technology may continue to offer RK as a method of correcting mild to moderate myopia.”  With medically necessary procedures, it’s understandable that rural communities have to accept care that isn’t as good as that available in urban areas, but is it right to subject them to blindly accept elective medical care that is known to be inferior simply because it is cheaper and easier for the surgeon Not to travel for a few hundred miles?  What if the patient is willing to travel?  Is that the standard of care you would like for your mother or your children?  
Why aren’t the following medical reasons mentioned instead of the Ophthalmologists’ costs?  “Higher-order wavefront aberrations were almost twice as high after RK than after PRK at pupil sizes of 4 and 6 mm.  Spherical aberration and coma were slightly higher after PRK than after RK.”  (http://www.journalofrefractivesurgery.com/showAbst.asp?thing=1885)
“RK is still performed on patients who have low to moderate degrees of nearsightedness and simply cannot afford the more expensive laser and surgical correction procedures.”
“After RK, almost everyone experiences some visual side effects. These visual side effects are usually mild and most often diminish over a few days to a few weeks. But there is a slight chance that some of these side effects won't go away completely, including light sensitivity, glare and halos. Serious complications to RK are extremely rare. Infection is the most worrisome complication and fortunately it can usually be eliminated with antibiotic medications.”
(http://www.joneseyecenters.com/index.cfm/procedures/radialkeratotomy)
“Without proper education, some patients mistakenly equate residual refractive error to a surgical complication instead of a nuisance. “  (http://www.revoptom.com/body/articles/10_2001/ro257.htm)
“The clinical study of CK indicated that most patients continue to not need glasses” and “is considered a less invasive alternative to LASIK”.  “We should be able to correct most cases of hyperopia, and our initial studies indicate ultimately, presbyopia.”
Are the chances really “slight” or “small”?  What does “rare” mean to you, to me, to your neighbor?  1 in 1,000,000?  1 in 100,000, 1 in 10?  Does this type of vague explanation of the likelihood of having permanently damaged vision fully inform anyone “about the risks and benefits of laser surgery compared with other available treatments”?

How long is the FDA and AAO going to allow this to continue?  Have you thought about it?  This is bad for the patient, but this is worse for you.  Enough said.