Food and Drug Administration
Center for Devices and
9200 Corporate Blvd.
Rockville, MD 20850
Dear Eye Care Professional:
The Food and Drug Administration (FDA) is writing to provide you with important information about the promotion and advertising of FDA-approved lasers that are used during laser-assisted in-situ keratomileusis (LASIK) procedures and to let you know where you may get additional information, if needed.
On April 25, 2008, FDA’s Ophthalmic Devices Panel held a public meeting to discuss issues concerning post-market experiences with LASIK procedures. Both at the meeting and through submissions to a subsequently established public docket, the FDA has received information, comments, and complaints from interested persons regarding the promotion and advertising of LASIK procedures and the FDA-approved lasers used in LASIK procedures. The FDA has received complaints that eye care professionals’ advertisements for LASIK procedures and FDA-approved lasers used for the LASIK procedures failed to inform consumers of the indications, limitations, and risks associated with LASIK procedures and the approved lasers used for the LASIK procedures.
The FDA believes that eliminating deceptive or misleading health-related advertising claims is an important part of protecting the public health.
The FDA has approved several lasers intended for use in LASIK procedures. A list of all FDA-approved lasers for LASIK procedures may be found at: Devices@FDA.
This Web page also provides information about the scope of the intended uses for each FDA-approved, restricted device and the risks associated with the use of the device. The information about risks may include warnings, precautions, side effects, and contraindications.
These lasers are restricted medical devices that have been approved for particular uses and have risks associated with their use. Advertising and promotional materials for FDA-approved lasers used during LASIK procedures must be truthful, properly substantiated and not misleading.
A restricted device is misbranded under the Federal, Food, Drug, and Cosmetic Act (Act) if its advertising is false or misleading (21 U.S.C. 352(q)). In determining whether the advertisement is misleading, the FDA takes into account not only representations made or suggested by statement, word, or design, but also the extent to which the advertisement fails to reveal facts material in the light of such representations, or material with respect to consequences which may result from the use of the device to which the advertisement relates under the conditions of use prescribed in the advertisement (21 U.S.C. 321(n)).
Further information about LASIK procedures and FDA’s current LASIK activities can be found on the FDA LASIK Web site.
If you become aware of an advertisement for any of these restricted devices that may be in violation of the Act, please forward it to FDA’s Center for Devices and Radiological Health (CDRH), Office of Compliance at the address listed above. Questions concerning this letter may be directed to Ann Simoneau, Regulatory Counsel, CDRH, Office of Compliance at (301) 796-5514.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and