Exposing the LASIK Scam

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 Post subject: FDA links
PostPosted: Thu Dec 08, 2005 2:56 am 
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Joined: Thu Nov 24, 2005 9:06 pm
Posts: 297
From time to time I am asked for certain FDA links. Here are the most common links people ask for:


FDA approved lasers and links to approval orders, Summary of Safety and Effectiveness, and labeling (Patient Information Booklets and Profession Use Manuals):
http://www.fda.gov/cdrh/LASIK/lasers.htm

The guidance for refractive surgery lasers:
http://www.fda.gov/cdrh/ode/2093.html

Discussion points for the expansion of the guidance for refractive surgery lasers:
http://www.fda.gov/cdrh/ode/rslaschk.html

Guidance for microkeratomes:
http://www.fda.gov/cdrh/ode/guidance/1376.html

The original LASIK study transcripts, July 1999, VISX and Summitt:
http://www.fda.gov/ohrms/dockets/ac/99/ ... 3528t1.doc
http://www.fda.gov/ohrms/dockets/ac/99/ ... 3528t2.doc

FDA warning letter to the surgeons who conducted the original LASIK study:
http://www.fda.gov/foi/warning_letters/m2875n.pdf

If anyone needs the transcript of the September, 1999 panel meeting to draft the guidance for microkeratomes, please post your request here and I'll email it to you. For some reason I can't locate the link, but I have the file.

Link to file a report (MDR) with the FDA about your bad refractive surgery:
https://www.accessdata.fda.gov/scripts/medwatch/

To do a search on previously filed MDRs:
http://www.accessdata.fda.gov/scripts/c ... search.cfm
You can type in LZS for lasers, HNO for microkeratomes. For Intralase, type in Intralase. You should read some of these in your spare time!


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 Post subject:
PostPosted: Sun Oct 14, 2007 9:07 pm 
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Joined: Sat Nov 26, 2005 1:23 pm
Posts: 2080
To look up past and upcoming advisory panel meetings:

http://www.accessdata.fda.gov/scripts/c ... search.cfm

_________________
Broken Eyes

"The price good men pay for indifference to public affairs is to be ruled by evil men." Plato


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