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Friday, Oct 16, 2009 @09:19am CDT (Washington, DC) -- Federal health regulators are concerned about side-effect reporting systems at 17 LASIK vision correction centers in the U.S.
The agency says the systems in place are poor. However, the FDA pointed out that no problems have been found with the laser devices used in the procedure. Clinics are supposed to report side effects to equipment manufacturers and the FDA. Patients get the procedure to avoid having to wear glasses or contact lenses, but may have to deal with blurred and double-vision as side effects. LASIK procedures have generated more FDA attention recently. In May, the agency told providers to make risks clear in their advertisements. The FDA's outside advisers had previously urged that more be done to protect consumers. LASIK is short of Laser-Assisted In Situ Keratomileusis and is intended to improve vision by cutting a flap in the eye and then using a laser to reshape the cornea.
(Copyright 2009 by VERTEXNews/Newsroom Solutions) |
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