Laser for Cataract and Corneal Procedures Cleared by FDA

Emma Hitt, PhD

August 09, 2012

August 9, 2012 — The Victus femtosecond laser platform, manufactured by Bausch + Lomb and Technolas Perfect Vision, that is designed to be used in both cataract and corneal procedures has been granted 510(k) clearance by the US Food and Drug Administration (FDA).

The platform is intended for creation of a corneal flap for laser-assisted in situ keratomileusis (LASIK) surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery. According to the companies, the Victus platform is the first femtosecond laser capable of supporting cataract and corneal procedures on a single platform.

The platform may offer greater precision compared with manual cataract surgery techniques by allowing for more precise, controllable, and centered capsulotomy. In addition, laser refractive cataract surgery carried out by the Victus platform may require less phaco energy and time during lens fragmentation and improve intraocular lens placement.

The product also received CE mark approval in Europe in December. The companies state they plan to submit applications for additional indications to the FDA.

Femtosecond lasers emit optical pulses of extremely short duration that avoid transferring heat or shock to the material being cut and can make extremely precise surgical incisions. The technology was developed in the early 1990s and the first commercial platform was introduced in 2002.

According to a report by Medical Device Daily, Calvin Roberts, MD, executive vice president and chief medical officer at Bausch + Lomb, stated that there are other femtosecond laser technologies, but the Victus platform is unique because it combines optical coherence tomography imaging with a femtosecond laser, which "allows us to make sure that we're able to do the cutting with the laser in exactly the right place that we want to do it. So really, we have two brand new technologies coming together to do this."

Another aspect that sets the Victus platform apart, said Dr. Roberts, is that it has a higher pulse rate for the laser and a curve 2-piece patient interface, which helps position the eye correctly.