Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas

• Published in: Archivos de la Sociedad Española de Oftalmología (English ed.) Vol. 98; no. 12; pp. 723 - 726
• Main Authors: Donate, J., Arias-Barquet, L., Ruiz-Casas, D., Larra-Mateos, E., Pastor, J.C.
• Format: Journal Article
• Language: English
• Published: 01-12-2023
• ISSN: 2173-5794; 2173-5794
• DOI: 10.1016/j.oftale.2023.10.006

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreo and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.