FDA interest in LASIK continues: ASCRS webinar clears confusion about medical device reporting and LASIK advertising

On December 10, ASCRS held a Web seminar with FDA officials to review and clear up confusion about Medical Device Reporting (MDR) requirements and FDA concerns about LASIK advertising. A recording of the Webinar is now available to all ASCRS members on disc for a fee of $50.00. Contact JCiccone@ascrs.org for additional information.
For the past two years, U.S. Food and Drug Administration (FDA) interest in LASIK has been growing. A small group of anti-LASIK activists have been particularly active on the Internet for some time. Their communications and petitions filed with the FDA resulted in an April 2008 open public discussion for dissatisfied LASIK patients to express their concerns. Following that, the FDA, initially working with ASCRS and the American Academy of Ophthalmology, began work on a LASIK Quality of Life study, which is now getting underway. In May of 2009, the FDA issued a letter to ophthalmology practices expressing concern about advertising claims in LASIK advertising. And in October 2009, the FDA issued a warning letter to 17 ambulatory surgical facilities (often referred to as ambulatory surgical centers) citing a failure to have proper procedures in place for medical device reporting. Most recently, the FDA extended for one year, its docket for gathering patient comments about unsatisfactory outcomes.
The Web seminar, entitled The FDA and LASIK: What you need to know right now about Medical Device Reporting and LASIK Advertising, featured background on the FDA’s recent interest in LASIK, a briefing on the MDR regulations, adverse events, common scenarios to aid understanding of the regulations, and a question and answer period. The webinar recording should help doctors and administrators come away with a clear understanding of what is expected.
The Web seminar featured the following FDA speakers:
James Saviola, OD—CAPT USPHS, Ophthalmic and ENT Network Leader, Office of the Center Director, Center for Devices and Radiological Health (CDRH)
Timothy A. Ulatowski—Director, Office of Compliance, CDRH
Sharon Kapsch—Chief, Reporting Systems Monitoring Branch, CDRH
Victoria A. Schmid—Consumer Safety Office, Office of Surveillance and Biometrics/Division of Postmarket Surveillance/Reporting Systems Monitoring Branch, CDRH

LASIK Advertising

The Guidelines for Refractive Surgery Advertising, have been issued as an joint updated policy statement of the American Society of Cataract and Refractive Surgery, the American Academy of Ophthalmology (Academy), and the International Society of Refractive Surgery of the Academy. The Guidelines are available on the ASCRS website member’s section.
The guidelines are designed to help ophthalmologists provide truthful, informative advertising of refractive surgery. In addition to their ethical obligations, the guidelines note, ophthalmologists must be aware of their legal obligations in connection with the promotion of services.
While the guidelines cannot address every possible advertising claim that could be made in support of refractive surgery, they address specific types of claims that could confuse consumers and/or have been subject to Federal Trade Commission (FTC) review. Examples of permissible claims as well as claims that might be considered confusing or misleading are provided and discussed.
The Webinar was supported by an educational grant from the ASCRS Foundation, the American Society of Ophthalmic Administrators, and the American Society of Cataract and Refractive Surgery and is available to members on ASCRS.org under the government relations tab.

ABOUT THE AUTHOR

John Ciccone is director of communications for the American
Society of Cataract and Refractive Surgery. Contact him at 703-591-2220.