Trifocal vision takes the U.S. stage as BVI’s FINEVISION HP earns long-awaited FDA nod.
The U.S. Food and Drug Administration (FDA) has approved BVI Medical’s (Massachusetts, USA) FINEVISION HP Trifocal IOL for commercial use. This decision gives American surgeons and their patients access to a lens that has been in clinical use internationally for over a decade.
BVI announces the news on its LinkedIn page
“FINEVISION HP redefined premium cataract surgery and continues to set the gold standard in premium IOL innovation,” said Shervin Korangy, president and CEO of BVI, in a news release. “This FDA approval marks a pivotal step in expanding our IOL portfolio in the United States, supporting our mission to deliver best-in-class visual outcomes for patients globally.”
Clinical evidence and performance
The FDA’s decision followed a U.S.-based clinical evaluation assessing the lens’s safety and visual outcomes in local populations. The findings were consistent with long-term data from international markets where the lens has been used extensively in both public and private healthcare settings.
Building on that evidence, studies conducted in Europe and the United States have demonstrated consistent visual outcomes with the FINEVISION HP trifocal configuration. Its diffractive optic evenly distributes light across three focal points, maintaining contrast sensitivity while reducing glare and halos.
READ MORE: ESCRS 2025 Roundup: Science, Community and The Future of Ophthalmology
In the U.S. clinical trial, most patients achieved functional vision without the need for corrective eyewear in their daily lives, mirroring outcomes observed internationally.
Dr. Vance Thompson, one of the U.S. investigators, stated, “The FINEVISION HP trifocal IOL reflects innovation in optic design, and I’m pleased to have been part of the U.S. study evaluating its performance. This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients.”
Market context
The approval positions FINEVISION HP within an already competitive U.S. market for premium IOLs, alongside offerings from major players such as Johnson & Johnson Vision (Florida, USA), Alcon (Geneva, Switzerland), and ZEISS (Oberkochen, Germany). Each manufacturer focuses on improving postoperative visual outcomes through unique optical strategies, from extended depth of focus (EDOF) to minimizing photic phenomena.
Background and development
Developed in collaboration with French ophthalmologist Dr. Damien Gatinel and Christophe Pagnoulle, director of Research and Development at BVI, FINEVISION HP was the first intraocular lens to introduce a trifocal optical design when it debuted in Europe.
Originally introduced more than 15 years ago, FINEVISION HP was designed to overcome the limitations of earlier multifocal lenses that split light into just two focal points. Its trifocal configuration redistributes light into three distinct focal lengths—far, intermediate and near—enhancing visual function across a broad range of everyday activities.
According to BVI, the lens is built on the company’s POD platform and incorporates CoPODize light management technology to optimize contrast and reduce visual artifacts. It also features a double C-loop, four-point haptic system that enhances stability and centration within the capsular bag following implantation.
READ MORE: Smart Tech in Refractive Surgery
Availability
The FINEVISION HP will roll out across the United States over the coming year, with its official launch taking place at the American Academy of Ophthalmology (AAO) Annual Meeting from October 18-20, 2025, in Orlando, Florida (Booth No. 3521).
Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.