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Intralase FS and Excimer Lasers recalled?


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Intralase FS and Excimer Lasers recalled?, Randy - Tahaw, VA, 5/03/2005
answer, William B. Trattler, MD Miami, FL 5/06/2005, (#1)
LASER TYPES FOR LASIK, Safala - Mumbai, MA, 5/31/2005, (#2)
Response, Glenn - Sacramento, CA, 5/31/2005, (#3)

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"Intralase FS and Excimer Lasers recalled?"
Posted by Randy - Tahaw, VA on 18:52:41 5/03/2005
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I can not find these lasers on the FDA list of approved lasers! http://www.fda.gov/cdrh/LASIK/lasers.htm

I did not know that Lasers could be not approved at the time of my surgery when my doctor used these lasers on my eyes.

Now I have ghosting in my left eye, and minor night starbursting!

I have read were both these lasers were recalled in the past but... I wondering if they could of been fixed and reapproved by the FDA.

Please help me. I'm afraid my doctor will try to tell me they have been approved even if they haven't been!

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1. "answer"
Posted by William B. Trattler, MD on 22:29:54 5/06/2005
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The intralase laser has been approved for a number of years. it is the laser used to cut the flap, so it would not be on the FDA website with the "excimer lasers" such as Autonomous, VISX, Nidek, etc.

Bill Trattler, MD
Miami, FL

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2. "LASER TYPES FOR LASIK"
Posted by Safala - Mumbai, MA on 12:19:08 5/31/2005
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any clue or idea on how good the new wavelight laser is?????
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3. "Response"
Posted by Glenn - Sacramento, CA on 15:09:54 5/31/2005
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At http://www.fda.gov/cdrh/LASIK/lasers.htm you will find a list of excimer lasers used for LASIK, IntraLASIK, PRK, LASEK, and EpiLASIK. At http://www.fda.gov/cdrh/PDF2/p020050.html you will find the FDA approval order for the Wavelight Allegretto excimer laser for myopia (nearsighted) vision correction, and at http://www.fda.gov/cdrh/PDF3/p030008.html you will find the hyperopia (farsighted) vision correction approval order.

All approval orders have outcomes information derived from the clincal trials. You may want to compare the lasers, HOWEVER no amount of technology can compensate for an inferior surgeon. Clinical trials are conducted by the best doctors in the business and the doctor you select may not be in that class. Anyone considering refractive surgery needs to evaluate the quality of the surgeon first, and equipment second. I suggest you use our 50 Tough Questions For Your Doctor to help you evaluate a potential surgeon.

You can review a Summary of Safety and Effectiveness for the Intralase femtosecond laser microkeratome at http://www.fda.gov/cdrh/pdf/k993153.pdf

Glenn Hagele
http://www.USAEyes.org

I am not a doctor.

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