Reporting serious incidents in medical devices used in glaucoma surgery. Proposing ideas (III)

Abstract

The implementation of the Medical Device Regulation (MDR) forces clinicians to identify and report any serious incidents related to the use of medical devices to the Health Authorities. To address uncertainties about what constitutes a serious incident, a working group composed of members of the Spanish Glaucoma Society (SEG) and the Cluster of Ophthalmology and Vision Sciences (Cluster4Eye) has developed a guiding document. This resource aims to assist less experienced ophthalmologists in recognizing specific incidents associated with glaucoma surgery that, in the team's view, are uncommon or could potentially result in significant harm to patient function. This list is not exhaustive and will remain open to updates based on feedback received.

Keywords: Cirugía del glaucoma; Glaucoma surgery; Incidentes graves; Medical device regulation; Medical devices; Productos sanitarios; Real decreto 192/2023 del ministerio de sanidad; Royal decree 192/2023 of the ministry of health; Serious incidents.