Exposing the LASIK Scam
http://lasikscam.com/

FDA links
http://lasikscam.com/viewtopic.php?f=8&t=100
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Author:  Bill [ Thu Dec 08, 2005 2:56 am ]
Post subject:  FDA links

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!

Author:  Broken Eyes [ Sun Oct 14, 2007 9:07 pm ]
Post subject: 

To look up past and upcoming advisory panel meetings:

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

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