FDA's LASIK Website

Although I feel the FDA has protected many doctors, companies, and themselves, they still have an informative LASIK Website.

Link To Site

Is ANY Laser really safe?

Not just investigational lasers, but those WITH approval from the FDA...

Alcon lasers

There were a whole bunch of new MDRs filed in the Maude database during December about breakdowns of Ladarvisions. They make interesting reading. Go to:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

(Type in "ladarvision" and search)

"CUSTOMCORNEA" into the search and got this one:  "Alcon customcornea & ladarvision 4000 wavefront lasik machines were used to preform enhancement surgery on left eye after original lasik in 2003. Enhancement surgery made eyesight worse; nearsighted again with multiple vision effect when looking at point of light. 2nd, 3rd, 4th opinions from other drs confirm irregularities in cornea from enhancement surgery and all of them say that the alcon customcornea wavefront measurement device and the ladarvision laser should not be used for enhancements because the software is not sophisticated enough and is too unstable."  Not only their machines, but their stock as well:

http://finance.messages.yahoo.com/bbs?.mm=

FN&action=m&board=1604339425&tid=acl&sid=1604339425&mid=2932

CODE OF FEDERAL REGULATIONS 812.7

CODE OF FEDERAL REGULATIONS 812.7

And promotion of an Investigational Device.

Read More

FDA Warning for Risk of Dry Eye Complications

 

http://www.fda.gov/cdrh/LASIK/risks.htm

Quote:

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.

 

It does happen!  And the people I've spoken to with these complications let you know the risks are severely down-played by the FDA.  These symptoms are VERY painful!

 

 

And doctors want patients to think that DLK and infectious keratitis just happen for no reason...

 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41874

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=41818

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=25688

Ophthalmic Devices Panel Meetings

 

This FDA panel meeting has a rather disgusting section where concealing the fact that refractive surgery induces dry eye from the consumer is discussed. The panel decided not to require that ALCON disclose that dry eye after refractive surgery is an industry-wide problem... because they hadn't required other LASER companies to include dry eye warnings in their labeling previously. So they claimed it wouldn't be FAIR to ALCON to have to admit in their labelling that refractive surgery induces dry eye. How about being fair to patients so that they can be properly informed about LASIK dry eye BEFORE they decide to have surgery?

Loss of corneal nerve density averaging more than 40% at the 3 year point after LASIK? No thank you!

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc  

http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3883t1.doc  

This link will allow you to find transcripts of all Ophthalmic Devices Panel meetings. Click on the year, then scroll down and look for Ophthalmic Devices.

http://www.fda.gov/ohrms/dockets/ac/acmenu.htm

Before you start clicking and reading, it helps to know which meetings were called to review lasers for refractive surgery.

Here's a link to the summaries of these meetings from 1997 through 2000:

http://www.fda.gov/cdrh/odp.html

More recent meeting summaries can be found at this link:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm

Click on "Ophthalmic Devices Panel", "Past Meetings".

FDA - Your Opinion?

http://www.lasikflap.com/forum/viewtopic.php?p=1769#1769

 “I hate the damn FDA. Its one thing for the laser makers to lie but it's another thing to know that your life ended because the damn FDA was too ignorant, too careless, or too corrupt to want to do it's job to stop them.”    

<<>>

http://www.lasikflap.com/forum/viewtopic.php?t=452 

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“the FDA says they dont regulate the practice of medicine. but lying to the FDA in order to perpetrate fraud on the public is not medicine. therefore, it is regulated by the FDA.”

“so the FDA can do something if its wants to. the question is whether the FDA itself is so corrupted by special interests that it doesnt want to. my guess is that it is. how else would research that was obviously deceptive make it through the opthalmic devices panel and be approved? if the fda took some kind of action, it might well have to admit to millions of consumers that they are facing long term damage to their vision. it could cause a lot of embarassment. so the fda is silent, just like almost everyone is silent.“

Available to the Public

Available to the Public

Over 1,000 pages of additional documents (now available on CD) are available to the public on request to this website. Please email me for more details.

Need To Contact The FDA?

GOOD LUCK! These wonderful people have helped me extensively ( NOT! ). If you're expecting help, expect a runaround:

Andrew VonEschenbach - ACTING COMMISSIONER OC
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Les Weinstein - OMBUDSMAN (CDRH)
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Christine Kellerman –SECRETARY (for Les Weinstein) (OA)
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Matthew Tarosky - SR SUP REGULATORY O
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Linda S Kahan - DEPUTY DIRECTOR CDRH
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Everett Beers, Dr. – SUPV GENERAL ENGINEE
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Michael Marcarelli – SR SUP REGULAT O
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Viola Sellman – SUPV CONSUMER SAFETY OFCR
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Barbera Stellar – PUBLIC HEALTH ADVISOR
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Timothy Ulatowski – DIR OFFICE OF COMPLIANCE
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Joy Lazaroff – SUPVY PARALEGAL SPECIALIST
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Ronald Swann - SUPV CONSUMER SAFETY OFCR
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Mark Weinstein - Assoc. Dep Dir CBER/OBRR
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Gene Allen – PUBLIC HEALTH ADVISOR
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Malvina Eydelman - SUPV MEDICAL OFFICER
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Jean Toth-Allen - PHYSICIST
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Jerry Dennis – CONSUMER SAFETY OFFICER
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Linda Lyons Drager (ODE) – SECRETARY (OA)
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Pat Storer – CONSUMER SAFETY TECHNICIAN
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Laurie Lenkel – REGULATORY COUNSEL
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Steven Kendall - SUPV CONSUM SAFETY OFFICE
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Susan Setterberg (phila) - REG FOOD AND DRUG DIR
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Ed McDonald (phila) - CONSUMER SAFETY OFFICER –
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Steven Kane (phila) - CONSUMER SAFETY OFFICER –
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Ronald Stokes (phila) - CONSUMER SAFETY OFFICER –
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No longer with the FDA or listed on employee directory:

Lester Crawford 
Mark McClellan 
A. Ralph Rosenthal
Levering Keely –
Harold Pellerite –
ROBERT ZIMMERMAN (phila) – REGION SUPV -
DEBRA WOLF –

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