Silver Spring, MD--Five eye-care providers were warned in letters from the U.S. Food and Drug Administration (FDA) to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as laser-assisted in-situ keratomileusis (LASIK). The FDA found that the providers’ advertisements and promotional materials did not offer consumers adequate information about associated laser surgery risks, as well as warnings and possible adverse events.
The five providers that received FDA Warning Letters were the 20/20 Institute Indianapolis LASIK (Indianapolis, IN), Scott Hyver Visioncare (Daly City, CA), Rand Eye Institute (Deerfield Beach, FL), the Eye Center of Texas (Bellaire, TX), and the Woolfson Eye Institute (Atlanta, GA).
"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 (CDRH). "But providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection."
In refractive surgery, precise and controlled removal of corneal tissue by a special laser permanently reshapes the cornea and changes its focusing power. LASIK is one type of vision correction surgery that uses refractive lasers to correct nearsightedness, farsightedness, and astigmatism, and includes such common risks as dry eye syndrome (which can be severe); the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and even loss of vision.
The FDA may take further regulatory action, such as seizure, injunction and civil money penalties, against providers who do not correct their advertising and promotion to address the concerns. In addition, the FDA issued letters in May 2009 and September 2011 to eye care professionals nationwide explaining the agency's concerns about improper advertising and promotion of FDA-approved lasers. The FDA also issued letters in March 2012 to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology, providing additional information about disclosing risk information in eye care professionals' advertisements and promotional materials concerning FDA-approved lasers intended for LASIK.
The FDA website includes information on the risks and benefits of LASIK, and provides access to the labeling for FDA-approved lasers used in LASIK. The FDA encourages consumers considering LASIK to understand what might make them poor candidates for the procedure, the risks and limitations of the procedure and the particular laser that would be used to perform the procedure. The FDA also recommends that consumers consult an experienced eye care professional to know what to expect before, during, and after LASIK surgery and reminds consumers that eye surgery such as LASIK is irreversible, that not all patients will achieve optimal results, and that some patients may need additional procedures. Click here for more information on LASIK for consumers from the FDA.
SOURCE: U.S. Food and Drug Administration; www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm332713.htm