Abstract
Purpose :
Recalls of ophthalmic implants are an important safety issue for patients and clinicians.The aim of this study is to characterise ophthalmic implants recalled over a 15-year period by the US Food and Drug Administration (FDA).
Methods :
All FDA recalls of ophthalmic implants issued from 2004 to 2019 were included in this retrospective analysis. The following FDA databases were used: Medical device recalls, 510(k), Pre-market authorisation (PMA), Production classification, Total Product Life Cycle (TPLC) and Manufacturer and User Facility Device Experience (MAUDE). Data were collected on product type, classification, country, recall number, FDA recall classification, reason for recall, recall initiation date, and recall report date.
Results :
There were 799 pre-market approvals for ophthalmic implants between 2004 and 2019. A total of 44 recall events occurred during this period. These recalls affected 913,704 units distributed across the global market. Of the ophthalmic implants recalled, 80% (35/44) were class III devices. 9% (4/44) of recalls, affecting 175,898 units, were high risk, a situation in which there is a reasonable probability that exposure to the product will cause serious adverse health consequence. Most of high risk recalls involved explantation of the recalled implant; however, the absolute number of patients affected could not be determined. 80% (35/44) of recall events posed a moderate risk, as determined by the FDA. The most common causes for recall related to intraocular lens implants were mislabelling of dioptre power and manufacturing process controls. Reported device problems are described according to type of implant. Amongst intraocular pressure lowering implants and aqueous shunts, the most common cause for recall were device design/function and package mislabelling. Reported device problems were device malposition and device obstruction.
Conclusions :
Important information is gained by analysing the reasons for recalls and their clinical consequences. The results of this study can inform effective safety reporting systems for the post-market surveillance of ophthalmic implants and better standardisation of the FDA medical device recall database.
This is a 2020 ARVO Annual Meeting abstract.