Major FDA medical device recalls in ophthalmology from 2003 to 2015

Objective: To assess recent high-risk ophthalmic medical device recalls. Methods: 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. Results: Twelve Class I ophthalmic device recall events were identified, collectively affecting over 68 million units in distribution. A median of 147,491 units (range 20 to 57,252,581) were recalled per event. 9 out of 12 recalls (75%) had at least one documented occurrence of an adverse event to a patient. Pre-market related issues accounted for one device recall (8%), post-market related issues accounted for nine device recalls (75%), and two device recalls (17%) were indeterminate. 510(k) clearance was the most common pathway to market, accounting for 50% of Class I recalls. Three devices were approved through pre-market approval (PMA) pathway, two devices were exempt from review, and one device failed to register with the FDA. Conclusion: Class I recalls surrounding ophthalmology are relatively infrequent compared to other medical specialties. However, given the impact of Class I recalls in the field, ophthalmologists have an impetus to advocate for stronger device regulation particularly in the context of post-marketing surveillance.