Mon Dec 24, 2012 12:27pm EST
(Reuters) – U.S. health regulators warned 5 eyecare providers to stop dubious graduation and graduation of refractive lasers used in eye medicine procedures such as LASIK.
The U.S. Food and Drug Administration found that a advertisements and promotional materials did not offer consumers adequate information about risks and probable side effects.
Warning letters were sent to certain eyecare centers in Indiana, California, Florida, Texas and Georgia.
“Providers whose graduation does not yield adequate risk information are anticipating out currently that a FDA is critical about consumer protection,” pronounced Steve Silverman, correspondence executive during FDA’s Center for Devices and Radiological Health in a matter posted on a agency’s website.
Surgery with refractive lasers is dictated to revoke a need for eyeglasses or hit lenses. It involves a dismissal of corneal hankie by a special laser and henceforth reshapes a cornea and changes a focusing power.
The many common risks of LASIK medicine embody dry eyes, a probable continued need for glasses, visible disturbances such as halos, starbursts or double vision, and even detriment of vision.
The FDA pronounced it released letters in 2009 and 2011 to eyecare professionals opposite a nation explaining a agency’s concerns about crude graduation and graduation of FDA-approved lasers.
It also released letters in Mar 2012 to a American Society of Cataract and Refractive Surgery and a American Academy of Ophthalmology, providing additional information about disclosing risk in eyecare professionals’ advertisements and promotional materials.
“The FDA reminds consumers that eye medicine such as lasik is irreversible, that not all patients will grasp optimal results, and that some patients might need additional procedures,” a FDA said.
(Reporting by Toni Clarke in Boston; modifying by Matthew Lewis)
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