FDA WARNING_LETTER - Eye Center of Texas - December 18, 2012

The FDA issued a Warning Letter to Eye Center of Texas on December 18, 2012, for promoting the VISX laser on its website in violation of the Federal Food, Drug, and Cosmetic Act. The VISX laser is a restricted device. The FDA found the website's "Lasik FAQ" page to be misleading, misbranding the device under sections 502(a) and (q) of the Act, and constituting a prohibited act under section 301(k).

Specifically, the website minimized and failed to reveal material facts regarding the risks associated with the VISX laser. While it mentioned dry eyes, "halo" effect, and glare, it minimized these by claiming they were "no worse than what most contact lens and eyeglass wearers often experience and usually diminish or disappear within 4-6 months," without adequate substantiation. The website also omitted other critical risk information, such as the possible need for glasses or contact lenses after surgery and the risk of vision loss.

The FDA requires Eye Center of Texas to immediately cease promoting the VISX laser in violation of the Act and take prompt action to correct the identified violations. The firm must notify the FDA in writing within fifteen business days of receiving the letter, detailing specific corrective steps, how future violations will be prevented, and providing documentation or a timetable for completion. Failure to comply may result in regulatory actions including seizure, injunction, and civil money penalties.