FDA clears BVI’s FineVision HP trifocal IOL for the US market

The FDA has approved BVI’s trifocal intraocular lens (IOL) (FineVision HP), adding to the range of advanced lens options available to US ophthalmologists and their patients.¹ This approval marks the US introduction of a lens that has been implanted in millions of procedures globally and is part of the company’s broader effort to expand its premium IOL portfolio in the US market.¹

Christophe Pagnoulle, director of research and development (R&D) with BVI, and ophthalmologist Damien Gatinel, MD, PhD, were instrumental in the development and launch of the lens, which marked a significant advancement in the field of premium IOLs, according to BVI.¹ As one of the earliest trifocal intraocular lenses on the global market, the device has been in clinical use for over 15 years and features a diffractive optic design that supports vision at multiple distances (far, intermediate, and near).¹

“FineVision HP redefined premium cataract surgery and continues to set the gold standard in premium IOL innovation,” said Shervin Korangy, president and chief executive officer of BVI, in a prepared statement.¹ “This FDA approval marks a pivotal step in expanding our IOL portfolio in the US, supporting our mission to deliver best-in-class visual outcomes for patients globally.”

The third-generation trifocal lens integrates the company’s POD platform design and technology (CoPODize) to balance light distribution and reduce visual side effects, and it features a double C-loop with 4-point haptics to promote stable positioning within the capsular bag.¹

“The development of [this lens] was a pivotal moment for ophthalmology, reshaping expectations for vision correction after cataract surgery,” said Gatinel, who oversees anterior segment and refractive surgery at the Rothschild Foundation in Paris, France.¹ “FDA approval in the US means even more patients will benefit from this breakthrough technology.”

Building on its established use internationally, the US clinical study (NCT04176965) provided additional data on the lens’ potential benefits for patients in the US. “[This] trifocal IOL reflects innovation in optic design, and I’m pleased to have been part of the US study evaluating its performance,” said study investigator Vance Thompson, MD, in the statement.¹ “This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients,” added Thompson, who serves as director of refractive surgery for Vance Thompson Vision in Sioux Falls, South Dakota.¹

Market introduction

The company is preparing a phased introduction of the trifocal IOL across the US over the next year, while continuing to scale manufacturing to meet anticipated demand.^1,2 A limited rollout in the US is planned starting this fall, with distribution expanding more broadly during the first 6 months of 2026.² To support the rollout, the company will showcase the IOL at its exhibitor booth (3521) at the American Academy of Ophthalmology (AAO) annual meeting in Orlando, Florida, October 18–20, 2025.²

The lens approval is a recent expansion to BVI’s surgical portfolio for the US, as the company earlier this year received 510(k) clearance from the FDA for its laser endoscopy ophthalmic system (Leos).^3,4 BVI was honored with 4 distinctions at the 2025 Medical Device Network Excellence Awards, recognizing its achievements in innovation, product launches, R&D, and investment initiatives.⁵

REFERENCES

1. BVI’s FINEVISION HP gains FDA approval, ushering in a new era of advanced trifocal IOLs for US patients. News release. BVI. October 14, 2025. Accessed October 14, 2025. https://www.bvimedical.com/bvis-finevision-hp-gains-fda-approval-ushering-in-a-new-era-of-advanced-trifocal-iols-for-u-s-patients/

2. BVI unveils what’s next at AAO 2025. BVI. Accessed October 14, 2025. https://www.bvimedical.com/aao2025/

3. BVI Medical announces approval of breakthrough technology: FDA 510(k) clearance of its laser endoscopy ophthalmic system: Leos. News release. BVI. April 17, 2025. Accessed October 14, 2025. https://www.bvimedical.com/us/bvi-medical-announces-approval-of-breakthrough-technology-fda-510k-clearance-of-its-laser-endoscopy-ophthalmic-system-leos/

4. Crago SM. BVI Medical receives 510(k) FDA clearance for glaucoma surgical system. Ophthalmology Times. April 17, 2025. Accessed October 14, 2025. https://www.ophthalmologytimes.com/view/bvi-medical-receives-510-k-clearance-fda-for-glaucoma-surgical-system

5. BVI recognized for breakthrough innovation, strategic growth, and product launches in 2025, marking a landmark year in eye care advancement. News release. BVI. July 9, 2025. Accessed October 14, 2025. https://www.bvimedical.com/us/bvi-recognized-for-breakthrough-innovation-strategic-growth-and-product-launches-in-2025-marking-a-landmark-year-in-eye-care-advancement/