Dear Eye Care Professional:

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) staff are aware that a number of questions have been raised by the eye care community concerning the promotion and advertising of the photo refractive keratectomy (PRK) procedure with the excimer laser and we have received complaints regarding some advertisements. We are writing to provide you with a general sense of what is expected and to inform you where you may get additional information if it is needed. The FDA recently approved two laser systems for photo refractive keratectomy, summit Technology Incorporated’s (Summit’s) SVS Apex Excimer Laser System and VISX, Incorporated’s VISX Excimer Laser System Models “B” and “C.”

Both FDA and FTC’s Bureau of Consumer Protection believe that all advertising and promotional materials for PRK should be truthful and substantiated and that consumers have sufficient information to make an informed decision. We believe an important protection for the public health results from eliminating deceptive health-related advertising claims. Advertising or promotion materials that discuss efficacy or safety should also contain enough information about the risks and limitations associated with PRK to prevent deception. For example, advertising that raises unrealistic consumer expectations such as “throw away your eyeglasses” without further qualification should disclose the limitations of the PRK procedure. Likewise, unsubstantiated claims related to success rates or long-term stability would be considered misleading and deceptive. However, reminder advertisements, intended only to notify consumers that PRK is available as part of the professional practice—for example, “Dr. Jones, experienced in PRK,” without more, would likely not need to include information as to risks.

Questions have also been raised concerning simultaneous bilateral surgery and LASIK. Both of these surgeries are outside the scope of current approved labeling. The FDA considers the practitioner’s discussion if bilateral surgery or LASIK with patients, as well as the decision to conduct either of these surgeries as the practice-of-medicine. (Note that the patient information booklet, provided by the manufacturers, recommends a three month period between eye surgeries.) However, FDA also expects manufacturers and practitioners to promote these lasers only within the scope of their approved intended use.

Questions concerning this letter may be directed to the FDA’s Center for Devices and Radiological Health, Promotion and Advertising Policy Staff at (301) 594-4639 or the FTC’s Bureau of Consumer Protection, Service Industry Practices staff at (202) 326-3270.

Sincerely yours,

Lillian J. Gill
Director
Office of Compliance
Center for Devices and Radiological Health

Dean C. Graybill
Associate Director
Service Industry Practices
Bureau of Consumer Protection
Federal Trade Commission

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