FDA 510(k) Clearance for VICTUS® Femtosecond Laser use in Lens Fragmentation

It’s two years since the Victus® Femtosecond Laser Platform from Bausch + Lomb, gained FDA 510(k) clearance for use in cataract and corneal procedures.  Now it has seen that clearance extended to include use in laser-assisted lens fragmentation during cataract surgery.

Background

The fragmentation procedure, which follows a capsulotomy, uses the femtosecond laser to split the cataractous lens into sections. This is followed by phacoemulsification for cataract removal. The VICTUS platform offers a number of different lens fragmentation patterns depending on the cataract grade and user preference. It is now one of the only femtosecond lasers in the U.S. with clearance for the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery.

Physician comments 

“Academic research has shown that cataracts pre-treated with lens fragmentation can require less phacoemulsification energy for removal,” said Y. Ralph Chu, M.D., founder and director of the Chu Vision Institute, Bloomington, MN. “In lower grade cataracts, we have seen up to a 50 percent reduction in the phaco energy required to remove the lens following lens fragmentation with the laser, compared with standard phaco.”

“The VICTUS femtosecond laser platform delivers major advancements in cataract and refractive surgery, with a combination of precision and simplification for several of the key procedures,” said Dr. Chu. “Laser-assisted capsulotomies and fragmentation may improve the consistency and precision of cataract procedures and will contribute to our ability to provide excellent post-surgical outcomes.”

Company comments

“Bausch + Lomb has made great progress building out a comprehensive and competitive product portfolio for ophthalmic surgeons, and today’s lens fragmentation clearance on the VICTUS platform further strengthens our offerings,” said Calvin Roberts, M.D., chief medical officer, Bausch + Lomb. “For cataract, refractive or retinal surgery, the more you look at Bausch + Lomb, the more you’ll see that we have the platforms, intraocular lenses, instruments, packs, and distribution partnerships that together are helping improve patients’ vision and eye health.”

Source: Bausch + Lomb, PR Newswire

Share your thoughts

Your email address will not be published. Required fields are marked *