B+L femtosecond laser platform cleared for corneal incisions

Bridgewater, NJ-The FDA has granted 510(k) clearance to Bausch + Lomb’s femtosecond laser platform (Victus) for the creation of incisions in the cornea of patients undergoing cataract surgery or other ophthalmic treatments requiring incisions in the cornea.

 “This innovative system was conceived as the backbone of the successful ophthalmic practice today-and tomorrow-and it represents Bausch + Lomb’s unwavering commitment to offering the very finest in IOLs, surgical instrumentation, and advanced procedures to our customers,” said Calvin Roberts, MD, chief medical officer, Bausch + Lomb.

The femtosecond laser platform is designed to support a comprehensive suite of cataract and corneal procedures in a single instrument. The new technology is designed to function along with existing advanced proprietary features, including a patient interface and real-time optical coherence tomography imaging to optimize each cataract procedure being performed.

In July 2012, the platform received 510(k) clearance in the United States for creation of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery. In February 2013, it received FDA clearance for arcuate incisions.

In Europe, the platform also has CE Marking for capsulotomy, lens fragmentation, arcuate corneal incisions, corneal incisions, LASIK flap, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments.