MASSDEVICE ON CALL — The FDA warned a handful of eye care providers to stop disseminating "misleading" information regarding their vision correcting surgical lasers used in procedures such as Lasik.
"The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated risks, as well as warnings and possible adverse events," according to the FDA warning.
Lasik laser-based eye surgery is intended to relieve a patient from dependence on glasses or contact lenses by reshaping the cornea to improve vision. The most common risks associated with Lasik procedures include severe dry eye syndrome, loss of vision and visual symptoms such as halos or glares.
"Advertising by many eye care professionals who perform laser vision correction surgery provides patients with the risk information that they need to make informed decisions," FDA Center for Devices & Radiological Health compliance director Steve Silverman said in prepared remarks. "But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection."
The warned eye care clinics were reported as the following:
- 20/20 Institute Indianapolis LASIK, of Indianapolis
- Scott Hyver Visioncare Inc., of Daly City, Calif.
- Rand Eye Institute, of Deerfield Beach, Fla.
- Eye Center of Texas, of Bellaire, Texas
- Woolfson Eye Institute, of Atlanta
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