FDA clears BVI’s FineVision HP trifocal

The U.S. Food and Drug Administration approved Beaver-Visitec International’s FineVision HP trifocal intraocular lens on October 14, 2025, clearing the device for use in adult cataract patients in the United States. FDA records list the application as PMA P240038 and identify the product as FineVision HP Trifocal IOLs. The approval added another presbyopia-mitigating lens to a U.S. cataract market that already includes several premium intraocular lens options. The FDA’s approval letter said the lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for visual correction of aphakia in adults with less than 1 diopter of pre-existing corneal astigmatism whose cataractous lens has been removed by phacoemulsification. The agency said the device is intended to improve intermediate and near visual acuity while maintaining distance visual acuity comparable to a monofocal intraocular lens. (accessdata.fda.gov) BVI said the FineVision HP is a hydrophobic acrylic trifocal lens with ultraviolet-absorbing and blue light-filtering properties. FDA safety and effectiveness documents describe it as a single-piece multifocal intraocular lens with a central optic and four open-loop haptics in a double C-loop design. The company has described the product as the first trifocal IOL and said it has a clinical history outside the United States stretching back more than 15 years, with millions of implantations globally. (accessdata.fda.gov) Vance Thompson, an ophthalmologist and study investigator quoted in BVI’s announcement, said he was pleased to have taken part in the U.S. study evaluating the lens’s performance. Damien Gatinel, the ophthalmologist BVI identified as a developer of the device, said U.S. approval would extend access to the technology to more patients. Those remarks came in BVI’s October 14, 2025 release announcing the FDA decision. (bvimedical.com) October 2025 coverage in Ophthalmology Times said BVI planned a phased U.S. introduction, beginning with a limited rollout in the fall and broader distribution in 2026. The same report said the company was expected to showcase the lens at the American Academy of Ophthalmology annual meeting. Trade coverage at the time described the approval as an addition to the premium-IOL segment, where surgeons weigh lens selection against patient-specific factors including ocular comorbidities. (bvimedical.com) February 10, 2026 brought the first U.S. implantations of the FineVision HP, according to Ophthalmology Management, which said the procedures marked the device’s clinical debut in the country after the October 2025 FDA approval. That report said the U.S. launch had moved from regulatory clearance into operating-room use. The FDA’s PMA database now lists FineVision HP under approved device records, alongside the approval order, labeling and summary of safety and effectiveness documents. (ophthalmologytimes.com) For surgeons and buyers tracking the next step, those FDA filings remain the primary public source for the device’s indicated use, labeling and post-approval documentation, while BVI has already begun the U.S. rollout it outlined after the October 2025 decision. (accessdata.fda.gov) (ophthalmologymanagement.com)