Exposing the LASIK Scam

FDA links
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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):

The guidance for refractive surgery lasers:

Discussion points for the expansion of the guidance for refractive surgery lasers:

Guidance for microkeratomes:

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:

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:

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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