As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure... Kluting's email says that "from our point of view we would like to see LASIK stopped immediately... Nearly all risks of LASIK are because the procedure is not safe. It's not because of the patient or a misfortune.
Read more...January 2011 Archives
Mounting evidence of problems inherent to the LASIK procedure led to the filing of the petition on 1/6/2011 by Morris Waxler, Ph.D., a former FDA insider. LASIK patient advocates started an online petition to collect signatures from the public in support of Waxler's petition. The online petition was circulated on FaceBook and other Internet websites.
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Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who has publicly said the agency "screwed up" when it approved LASIK vision enhancement lasers on his watch in 1997, petitioned the agency 1/6 to undo that mistake by "withdraw[ing] FDA approval (PMA) for all LASIK devices and issue a Public Health Advisory with a voluntary recall of LASIK devices in an effort to stop the epidemic of permanent eye injury caused by lasers and microkeratomes used for LASIK eye surgery."
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Glare, halos, dry eyes and loss of quality night vision are not just adverse events but life altering disabilites. Many in my post-LASIK patient population do not drive at night and cannot function indoors in low light situations. As far as dry eyes are concerned, many of these patients' eyes are so dry that they cannot sleep through the night without getting up to instill lubricating drops in their eyes.
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