Silver Spring, MD
—Eye-care professionals must adequately inform patients of the risks and consequences associated with refractive surgery performed with FDA-approved lasers when advertising and promoting such procedures, the agency’s Center for Devices and Radiological Health (CDRH) said in a recent letter to eye-care professionals.
Those who do not comply within 90 days of issuance of the Sept. 23 letter face regulatory action that could include warning letters, product seizures, injunctions, and civil money penalty proceedings, according to the agency.
At an April 2008 public meeting of the agency’s Ophthalmic Devices Panel, the FDA received feedback that advertising and promotion of laser refractive surgery, including LASIK, “often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures,” according to the letter. (See Ophthalmology Times’
coverage of the 2008 meeting at www.ophthalmologytimes.com/FDALASIK.
The FDA opened a public docket from September 2008 to September 2009, during which time the agency sought information and comments on the post-market experience associated with the use of LASIK-related devices, as well as information regarding potential barriers that might exist in providing the agency with feedback regarding LASIK procedures.
The agency issued a letter to eye-care professionals on the matter in May 2009 and reopened a public docket to receive additional information and comments about LASIK devices later that year. It continues to receive feedback related to “improper promotion and advertising practices by eye-care professionals,” according to the letter.
Those believing that advertising or promotional material concerning a refractive surgery device is false or misleading should contact the CDRH’s Office of Compliance at 10903 New Hampshire Ave., Silver Spring, MD 20993. Questions concerning the letter to eye-care professionals may be directed to Deborah Wolf, regulatory counsel, CDRH Office of Compliance, at 301/796-5732.
The FDA’s Web site provides a list of all FDA-approved lasers for LASIK (http://www.fda.gov/...168641.htm
) and also provides information about the scope of the intended uses of each laser and the associated risks. Information about LASIK procedures and current FDA activities relating to LASIK can be found on the FDA’s LASIK Web site (http://www.fda.gov/.../default - Ophthalmology Times eReport