Rand Eye Institute Draws FDA LASIK Warning By Tod Aronovitz | 01/15/13 | 0 Comment

The Rand Eye Institute of Deerfield Beach, Florida, is one of five eye care providers to receive a recent FDA warning letter regarding misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The other four firms were all outside of Florida.

The FDA’s letter to the Rand Eye Institute reads in part, “Lasers such as the VISX Star S4 Laser, which are used in refractive procedures such as laser-assisted in-situ keratomileusis (LASIK), are restricted devices…”

FDA rules state that a device is misbranded if its labeling is false or misleading. Of particular concern is that consumers considering LASIK surgery are not made aware of “material facts, including the consequences that may result from the use of the device.”

Common risks associated with the use of refractive lasers intended for LASIK procedures, according to the FDA, include but are not limited to:

  • Dry eye syndrome in mild to severe forms
  • Continued need for glasses or contact lenses after surgery
  • Vision disruptions such as halos, glare, or starbursts
  • Age-related loss of LASIK surgical benefits
  • Double vision, which the FDA describes as “debilitating”
  • Loss of vision

Click here for more details on common risks of LASIK surgery at the FDA’s LASIK website.

The Rand Eye Institute, founded in 1979 by William J. Rand, M.D., has grown to a staff of more than 100 health care professionals and is one of the largest comprehensive eye care and surgical facilities in the country, according to its website. In response to the FDA letter, the firm’s website has added warning advisories for consumers.

The Federal Trade Commission (“FTC”) also offers consumers useful reference materials on the basic safety tips for LASIK surgery.

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