Your question is fairly broad. Are you looking for something more proactive than waiting for adverse events? Have you included the ISO 10993 standard in your research? You might also want to search the US FDA database of adverse event reporting or guidance documents for ocular device materials (www.fda.gov).

@neil Rothman yes i have added the ISO standards and what I'm looking for is aany good approach for the methodology for materiovigilance on ocular medical devices. The most basic one i have found is the number of events by the population. As for the FDA database, I'll use it as well. Thank you for your suggestions

There are several other approaches for materiovigilance on ocular medical devices, in addition to observing patients for adverse events. Here are some examples:

Materiovigilance on ocular medical devices?

These approaches can be used in combination to provide a comprehensive evaluation of the safety and efficacy of ocular medical devices, and to ensure that patients receive the best possible care.

Materiovigilance is the continuous process of monitoring and evaluating the safety and performance of medical devices, including ocular medical devices, throughout their lifecycle. Ocular medical devices are used to diagnose, treat, or manage various eye conditions, such as cataracts, glaucoma, and refractive errors.

Materiovigilance on ocular medical devices involves monitoring and evaluating the safety and performance of these devices in clinical practice, and taking appropriate actions to minimize the risks associated with their use. Here are some examples of materiovigilance activities that can be carried out for ocular medical devices:

By carrying out materiovigilance activities, regulators, manufacturers, and healthcare providers can ensure that ocular medical devices are safe and effective, and that patients receive the best possible care.