FEB 27, 2014
Cataract/Anterior Segment, Cornea/External Disease
The U.S. FDA has approved Bausch & Lomb’s Victus femtosecond laser for making corneal cuts and incisions in patients undergoing cataract surgery or other ophthalmic treatment.
Victus previously received 510(k) clearance for the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea, and for anterior capsulotomy and arcuate incisions during cataract surgery.
In Europe, the Victus platform has received the CE Mark for capsulotomy, lens fragmentation, arcuate corneal incisions, corneal incisions, LASIK flap, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments.
The company says the product supports both cataract and corneal procedures in a single instrument and includes real-time OCT imaging.
“As we continue to gain clearances for additional procedures, we approach the day when surgeons can harness the full, inherent functionality and versatility of the Victus Femtosecond Laser Platform for their cataract and refractive patients,” said Calvin Roberts, MD, chief medical officer for Bausch & Lomb.