FDA Issues Additional Warning Letters to LASIK Clinics


The Food and Drug Administration has slapped several more LASIK facilities with warning letters for violations of the medical device reporting (MDR) regulations. Federal law requires surgical facilities to track and report adverse events related to FDA-regulated medical devices such as those used to perform LASIK. Critics of the LASIK procedure have long accused the LASIK industry and LASIK surgeons of systematically hiding widespread LASIK problems and ignoring the federal law. They point to common “side effects” such as chronic dry eyes and night vision problems, as well as risk of delayed complications such as flap dislocation, infection, and corneal ectasia. Ectasia results from weakness of the surgically-thinned cornea to maintain its shape, leading to progressive vision loss. Ectasia is generally treated by corneal transplantation. LASIK surgeons continue to deny the frequency and severity of these problems.

Links to recent FDA warning letters:


Saint Vincent Surgery Center
312 West 25th Street
Erie, Pennsylvania 16502


LasikPlus Vision Center
1390 Willow Pass Road, Suite 120
Concord, California 94520-7986


Vision Care Holding, LLC dba Lasik Vision Institute
3801 South Congress Avenue
Lake Worth, Florida 33461


TLC Vision Corporation dba TLC Plymouth Meeting
600 Germantown Pike Suite 160
Plymouth Meeting, Pennsylvania 19462


Vision Care Holdings, Inc. dba The LASIK Vision Institute
4771 McKnight Road
Pittsburgh, Pennsylvania 15237-3424

Also see: List of FDA Warning Letters to LASIK Clinics