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Abstract #126534 Published in IGR 25-2
Reporting serious incidents in medical devices used in glaucoma surgery. Proposing ideas (III)
Muñoz-Negrete FJ; López Vázquez A; Martínez-de-la-Casa JM; Pazos M; Giménez Gómez R; Pastor JCArchivos de la Sociedad Espanola de Oftalmologia 2025; 100: 356-361
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.
Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcalá, Madrid, Spain.
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