Several years ago, the US Food and Drug Administration (FDA) became aware that some patients were experiencing debilitating ocular and visual symptoms affecting their quality of life following laser-assisted in situ keratomileusis (LASIK). The FDA convened a team to compare the information amassed following the FDA approvals (ie, postmarket data) to the scientific evidence upon which the FDA based its approval decisions (ie, premarket data). The postmarket and premarket data showed that more than 90% of patients were satisfied with their outcomes; however, some patients were dissatisfied. While all FDA-approved lasers for LASIK1 undergo extensive nonclinical and clinical data evaluation prior to approval, the impact of the symptoms on the patients’ daily lives was not previously collected or reported to FDA by the health care community or manufacturers.
Eydelman MB, Tarver ME, Ferris F. Listening to the Patients—The Laser-Assisted In Situ Keratomileusis Quality of Life Collaboration Project. JAMA Ophthalmol. Published online December 08, 2016. doi:10.1001/jamaophthalmol.2016.4585