Major FDA medical device recalls in ophthalmology from 2003 to 2015.

Abstract

To assess recent high-risk ophthalmic medical device recalls. The publicly available Food and Drug Administration Center for Devices and Radiological Health database was mined for Class I (high-risk) ophthalmic device recalls from January 1, 2003 to December 31, 2015. The number of Class I ophthalmic device recalls was quantified. Additionally, recall characteristics and market entry data were determined for each device. Twelve Class I ophthalmic device recall events were identified, collectivel