January 14, 2013
From a 12/18/2012 FDA press release:
The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery 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.
The five providers that received FDA Warning Letters are:
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
“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,” said Steve Silverman, compliance director at FDA’s Center for Devices and Radiological Health. “But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.”
Continue reading press release
Read warning letter to Woolfson Eye Institute addressed to Jonathan Woolfson, M.D.