Reporting adverse incidents: intraocular lenses

The document provides guidance on reporting adverse incidents related to intraocular lenses (IOLs). It emphasizes the importance of timely and accurate reporting, particularly when a medical device vigilance system is in place. The guidelines outline procedures for reporting incidents, including serious adverse events, device failures, and unexpected adverse effects. Reporting is essential to ensure public safety and to improve IOL design and performance. This guidance should be read alongside MEDDEV 2.12/1, the guidelines on a medical devices vigilance system.