Ophtec B.V.

Ophtec B.V. specialises in ophthalmic devices, primarily producing phakic anterior-chamber intraocular lenses (such as the Artisan model) for correcting refractive errors without removing the natural lens. They also develop capsular tension rings and single-use ophthalmic surgical probes, which assist in intraocular surgeries like refractive lens exchange and cataract procedures.

Ophtec B.V. is based in the United States, which means its devices must comply with FDA regulations. Since these devices fall under Class III classification, they require premarket approval (PMA) to demonstrate safety and effectiveness before authorisation. The company’s U.S. location ensures alignment with FDA standards, including mandatory UDI listing for devices like the Artisan intraocular lens.

Ophtec B.V.’s devices, including the Artisan intraocular lens, are listed in the FDA’s Unique Device Identifier (UDI) database. This listing is critical because UDIs enable precise tracking, transparency, and traceability of medical devices in the supply chain, supporting patient safety and regulatory oversight. Listing in this database reflects compliance with FDA requirements for Class III devices.

Ophtec B.V.’s devices, such as the Artisan intraocular lens and capsular tension rings, are classified as Class III under regulatory frameworks. This classification is the highest risk tier, meaning these devices require premarket approval (PMA) to demonstrate safety and efficacy through rigorous clinical trials and data submission before they can be authorised for use. The stringent pathway ensures these complex devices meet strict standards for patient safety.