Global ophthalmic device manufacturer BVI has announced FDA approval for its FINEVISION® HP trifocal intraocular lens (IOL) — marking a milestone in premium cataract surgery and expanding access to advanced presbyopia-correcting lens technology for US patients.
Developed by BVI’s Director of R&D, Christophe Pagnoulle, in collaboration with Damien Gatinel, the FINEVISION HP was the world’s first trifocal IOL, pioneering a new standard in refractive cataract surgery more than 15 years ago. With millions of implantations worldwide and over a decade of clinical validation, the lens is now poised to enter the U.S. market for the first time.
"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," said Shervin Korangy, president and CEO of BVI.
FINEVISION HP’s patented diffractive optic design delivers balanced vision across far, intermediate, and near distances, minimizing visual disturbances such as glare and halos. The lens integrates BVI’s proprietary POD platform and CoPODize™ technology to harmonize light distribution, while a double C-loop, four-point haptic design ensures precise centration and long-term stability within the capsular bag.
“The development of FINEVISION HP was a pivotal moment for ophthalmology, reshaping expectations for vision correction after cataract surgery,” said Dr Gatinel, who played a key role in the lens’s development. "FDA approval in the U.S. means even more patients will benefit from this breakthrough technology.”
The US clinical study confirmed the lens’s strong performance, mirroring results from international experience. Vance Thompson, study investigator, noted: "The FINEVISION HP trifocal IOL reflects innovation in optic design... This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients."
BVI will begin a methodical US rollout of the FINEVISION HP over the coming year, supported by ongoing manufacturing capacity expansion to meet anticipated high demand.
Developed by BVI’s Director of R&D, Christophe Pagnoulle, in collaboration with Damien Gatinel, the FINEVISION HP was the world’s first trifocal IOL, pioneering a new standard in refractive cataract surgery more than 15 years ago. With millions of implantations worldwide and over a decade of clinical validation, the lens is now poised to enter the U.S. market for the first time.
"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," said Shervin Korangy, president and CEO of BVI.
FINEVISION HP’s patented diffractive optic design delivers balanced vision across far, intermediate, and near distances, minimizing visual disturbances such as glare and halos. The lens integrates BVI’s proprietary POD platform and CoPODize™ technology to harmonize light distribution, while a double C-loop, four-point haptic design ensures precise centration and long-term stability within the capsular bag.
“The development of FINEVISION HP was a pivotal moment for ophthalmology, reshaping expectations for vision correction after cataract surgery,” said Dr Gatinel, who played a key role in the lens’s development. "FDA approval in the U.S. means even more patients will benefit from this breakthrough technology.”
The US clinical study confirmed the lens’s strong performance, mirroring results from international experience. Vance Thompson, study investigator, noted: "The FINEVISION HP trifocal IOL reflects innovation in optic design... This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients."
BVI will begin a methodical US rollout of the FINEVISION HP over the coming year, supported by ongoing manufacturing capacity expansion to meet anticipated high demand.
