Abstract
Purpose :
Recently, the approval process of surgical devices has received increasing attention. In most surgical subspecialties, the 510(k) approval pathway for surgical devices, which involves a less rigorous process, leads to a higher rate of recall compared to the Pre-Market Approval (PMA) pathway. Recent recalls of Alcon’s Cypass™ and Revision Optics’ Raindrop™ have prompted analysis of Class 1 recalls of ophthalmic devices which found no association between devices that underwent 510(k) approval and subsequent recalls. We studied the recall reason for all recall classes, as well as the approval pathway of ophthalmic devices and its association with the rate of recall.
Methods :
The U.S. Food and Drug Administration Medical Device Recalls database was used to search for ophthalmic device recalls from January 2002-January 2019. The Manufacture Recall Reason was then analyzed and stratified into one of the following categories: sterility, labeling/shipping, hardware, software, and adverse effects/miscellaneous. PMA and 510(k) approvals of ophthalmic devices were gathered from the FDA databases for the five companies with both the highest number of recalls and ≥10 PMA or 510(k) device approvals. Recall status of these devices was checked in the FDA’s Medical Device Recalls database. The number of devices that underwent PMA approval and 510(k) approval that were subsequently recalled were compared using a Chi-squared test using SAS 9.4 ((SAS Institute Inc., Cary, NC).
Results :
There were 139 ophthalmic device recalls in January 2002-January 2019. Approximately 75% of ophthalmic device recalls were due to software (28.1%), hardware (25.2%), and labeling/shipping (21.6%) problems. 47 devices underwent PMA or supplemental PMA approval and 180 devices underwent 510(k) approval. 14 (29.8%) devices approved by PMA and 38 (21.1%) devices approved by the 510(k) pathways were recalled (p=0.21).
Conclusions :
Our analysis revealed 74.8% of recalls were due to software, hardware, or labeling/shipping problems. We did not find a statistically significant association between the 510(k) approval pathway and the future recall of the device. These results should prompt discussion on how to target software, hardware, and labeling/shipping problems to reduce recalls of ophthalmic devices. Further studies should examine what differentiates the ophthalmic device industry from industries which display an association between the 510(k) pathway and future recalls.
This is a 2020 ARVO Annual Meeting abstract.