FDA Denies 2014 LASIK Petition

FDA has denied a 2014 petition asking that the agency (1) require a Boxed Warning on LASIK devices concerning a high incidence of induced visual symptoms and dry eyes; and (2) send letters to the American Society of Cataract and Refractive Surgery and the American Academy of Ophthalmology to advise doctors of the Boxed Warning.

The denial letter says FDA has determined that (1) a Boxed Warning for excimer laser systems for LASIK surgery is not necessary to provide a reasonable assurance of safety and effectiveness and thus (2) there is no need for a letter to professional associations.

The letter notes a public docket was opened 7/28 to receive comments on the format and content of labeling specific to LASIK devices to be provided by doctors to prospective recipients of LASIK surgery. FDA says that if the draft guidance is finalized, it will recommend patient labeling to warn patients about visual symptoms and dry eye.