FDA WARNING_LETTER - Woolfson Eye Institute - December 18, 2012

The FDA issued a Warning Letter to Woolfson Eye Institute on December 18, 2012, for promoting the WaveLight Allegretto Wave Eye-Q Laser and the VISX Star S4 Laser on its website in violation of the Federal Food, Drug, and Cosmetic Act. These excimer lasers are restricted devices used in LASIK procedures.

The violations stem from the institute's website misbranding the devices under sections 502(a) and (q) of the Act, which state that a device is misbranded if its labeling or advertising is false or misleading. Specifically, the website promotes the lasers' accuracy, speed, and efficiency, and minimizes risks by stating "less than 1% of LASIK patients develop complications." However, the website fails to reveal material facts, including comprehensive risk information such as contraindications, warnings, precautions, and adverse events associated with these devices. Common risks like severe dry eye, need for post-surgery glasses/contacts, debilitating visual symptoms (halos, glare, starbursts, double vision), and vision loss were not adequately disclosed.

The FDA requires Woolfson Eye Institute to immediately cease promoting the devices in violation of the Act and take prompt action to correct the identified violations. The institute 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