Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
Dear Eye Care Professional:
On May 22, 2009, the Food and Drug Administration (FDA) issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures, including laser-assisted in-situ keratomileusis (LASIK). This letter followed an April 2008, FDA Ophthalmic Devices Panel public meeting, at which the agency received information that eye care professionals’ advertising and promotion often failed to properly inform consumers of the indications, limitations, and risks of refractive procedures and the lasers used for those procedures.