Post-market surveillance of ophthalmic implants: role of real-world evidence

Ophthalmic implants including intraocular lenses, glaucoma drainage devices, corneal inlays, and keratoprosthesis are transformative in vision restoration. While randomized controlled trials (RCTs) establish pre-market safety and efficacy, they are limited in scope, duration, and generalizability. Post-market surveillance leveraging real-world evidence (RWE) has become indispensable to detect long-term complications, refine clinical practice, and support regulatory oversight.

This article reviews the evolution of post-market surveillance from spontaneous reporting systems to structured registries, mandated post-approval studies, and digital innovations. It highlights global regulatory frameworks such as FDA, EU MDR, and ISO, alongside international registries like IRIS®, EUREQUO, and MAUDE. The expanding role of artificial intelligence, tele-ophthalmology, and smart sensors in accelerating safety signal detection is emphasized. Ethical, legal, and privacy considerations, including GDPR and HIPAA compliance, are also discussed, with attention to disparities in low-resource settings.

RWE is reshaping ophthalmic device surveillance by enabling early detection of rare adverse events, supporting value-based procurement, and guiding personalized implant selection. However, challenges remain in harmonizing regulatory pathways, ensuring patient privacy, and expanding infrastructure in resource-limited settings. Future priorities include fostering global data-sharing consortia, validating AI-driven analytics, and embedding continuous quality improvement to translate surveillance into safer, patient-centered care.