LASIK Providers Unclear on Risks

The FDA sent warning letters to four LASIK providers for promoting the procedure on their websites without adequate warning about the risks involved. According to the warning letters, Woolfson Eye Institute, Rand Eye Institute, Indianapolis Lasik, and ScottHyver Visioncare, violated the Food, Drug, and Cosmetic Act, which bans false and misleading statements from the labeling of foods, drugs, medical devices, cosmetics, and tobacco.

According to section 201(n) of the Act, 21 U.S.C. § 321(n), in determining whether a device’s labeling or advertising is misleading, the extent to which the labeling or advertising fails to reveal material facts, including the consequences that may result from the use of the device, must be taken into account.

All four providers touted the benefits of their LASIK procedures, making such claims as:

The combination of speed, control and precision of the WAVE® Eye-Q laser means that patients are likely to enjoy LASIK outcomes that are equal to or even better than what they experience using glasses and contact lenses.  For example, in the FDA clinical studies, 93% of the patients saw equal to or better than 20/20, and 76% better than 20/16.

and

Using the Wavelight Allegretto Wave® your Woolfson surgeon is able to apply tiny laser pulses to the cornea to sculpt its surface with the utmost accuracy.  The high-speed eye-tracker checks eye positions 4000 times per second to follow the eye’s fastest movements and ensure accurate placement of each laser pulse.  The Smart Energy Control feature further gives peace of mind that the amount of energy in the laser has been calibrated to exactly the right level.

But the companies, according to the FDA,  failed to “reveal material facts, including relevant risk information.”

Common risks include dry eye syndrome, which can be severe; the possible need for glasses or contact lenses after surgery; visual symptoms including halos, glare, starbursts, and double vision, which can be debilitating; and the loss of vision.

Any provider who fails to provide information on both is in violation of the above Act. Click here for more information on LASIK from the FDA.