FDA Warns Lasik Facilities on Misleading Website Copy

The FDA slapped four Lasik eye centers with warning letters for overstating the benefits of their products and failing to explain risks. The Dec. 18 letters — to 20/20 Institute in Indianapolis, Rand Eye Institute in Deerfield Beach, Fla., ScottHyver Visioncare in Daly City, Calif., and Woolfson Eye Institute in Atlanta — were posted to the FDA’s website Jan. 2. All four letters concern descriptions of the Wavelight Allegretto Eye-Q laser and VISX Star S4 Laser.
Devices & Diagnostics Letter