Suggestion of serious incidents in medical devices used in anterior segment surgery. Proposing ideas (II).

Abstract

The entry into force of the regulation on medical devices obliges ophthalmologists to identify and report possible serious incidents arising from their use. Faced with the doubts that may arise about what can or cannot be considered a serious incident, a working group of members of the Spanish Society of Refractive and Implant Eye Surgery (SECOIR) and the ophthalmology and vision sciences cluster (Cluster4Eye), have prepared a consensus document that aims to guide ophthalmologists on 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 in relation to the use of medical devices. Incidents related to the use of viscoelastics, anterior capsule dyes, intraocular lenses, and other items used in anterior segment surgery have been addressed.