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. Providers whose advertising does not provide adequate risk information are finding out today that the FDA is serious about consumer protection.
Vision correction surgery with refractive lasers is intended to reduce a person’s dependency on glasses or contact lenses. In refractive surgery, precise and controlled removal of corneal tissue by a special laser permanently reshapes the cornea (a part of the eye that helps focus light to create an image on the retina) and changes its focusing power. LASIK, which stands for Laser-Assisted In Situ Keratomileusis, is one type of vision correction surgery that uses refractive lasers to correct nearsightedness, farsightedness, and astigmatism.
The most common risks of LASIK vision correction surgery with refractive lasers include:
- 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
- loss of vision.
If you or a loved one have suffered injury without being given adequate information prior to your surgery, you may be entitled to compensation. Contact our John Foy and Associates personal injury lawyers today at 404-400-4000.