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Vol. 98. Issue 12.
Pages 723-726 (December 2023)
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Vol. 98. Issue 12.
Pages 723-726 (December 2023)
Short communication
Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas
Reporte de incidentes serios en productos sanitarios usados en cirugía intraocular. Proponiendo ideas
J. Donatea, L. Arias-Barquetb, D. Ruiz-Casasc, E. Larra-Mateosd,e, J.C. Pastore,f,
Corresponding author
josecarlos.pastor@uva.es

Corresponding author.
a Hospital La Luz, Quironsalud, Hospital Clínico San Carlos, Madrid, Spain
b Hospital de Bellvitge, Universidad de Barcelona, Hospitalet de Llobregat, Barcelona, Spain
c Hospital Ramón y Cajal, Hospital HM Montepríncipe, Madrid, Spain
d AJL Ophthalmic S.A., Vitoria, Spain
e Cluster4Eye, Valladolid, Spain
f IOBA, Universidad de Valladolid, Valladolid, Spain
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Table 1. SERV-Cluster4Eye working group’s serious incident proposal (not exclusive).
Abstract

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.

Keywords:
Medical devices
Intraocular surgery
Serious incidents
Mediccal Device Regulation
Resumen

La entrada en vigor del reglamento sobre productos sanitarios, obliga a los clínicos a identificar y reportar a las Autoridades Sanitarias los posibles incidentes serios derivados de su utilización. Dadas las dudas que pueden suscitarse sobre que puede o no considerarse incidente serio, un grupo de trabajo, creado por miembros de la Sociedad Española de Retina y Vitreo y el clúster de oftalmología y ciencias de la visión (Cluster4Eye) han elaborado un documento que pretende orientar a los oftalmólogos sobre algunos de los incidentes que, en la experiencia del equipo de trabajo, no son habituales o pueden causar un serio daño a la función del paciente.

Palabras clave:
Productos sanitarios
Cirugía intraocular
Incidentes serios
Medical Device Regulation

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