Serious incidents involving ocular medical devices reported to the AEMPS.

Abstract

The implementation of the Medical Device Regulation and Royal Decree 192/2023 not only requires manufacturers to enhance safety measures in the production of medical devices but is also complemented by additional regulations impacting hospitals, clinics, and healthcare personnel. Among these is the requirement to identify and report serious incidents to the Spanish Agency of Medicines and Medical Devices (AEMPS). To establish a baseline and evaluate the dissemination efforts of these concepts at the level of scientific societies and other organizations, serious incidents involving ophthalmic medical devices reported to AEMPS since 2018 and subject to health alerts have been identified. Although the percentage remains minimal, it is notable that issues with software or equipment such as surgical microscopes and Optical Coherence Tomography (OCT) are now being reported.