Catalys system cleared for corneal single-plane, multi-plane arc incisions

OptiMedica announced that the U.S. Food and Drug Administration has granted 510(k) market clearance for making single-plane and multi-plane arc incisions in the cornea during cataract surgery with its Catalys Precision Laser System, according to a press release.

“The FDA approval gives the OptiMedica Catalys instrument the full range of customized femtosecond laser treatment capacity for the manual parts of cataract surgery, including the main cataract and side-port incisions, arcuate corneal incision astigmatic correction, anterior capsulotomy, and cataract softening and prechopping,” William W. Culbertson, MD, chair of OptiMedica’s medical advisory board, said in an interview with Ocular Surgery News.

The system received CE mark approval for making single-plane and multi-plane arc incisions in March. It now has both CE mark approval and FDA market clearance for corneal incision as well as capsulotomy and/or lens fragmentation.

“[The system] allows cataract surgeons to perform precise astigmatism-correcting relaxing incisions in the peripheral or paracentral cornea intraoperatively,” Culbertson said.

The Catalys combines a femtosecond laser, 3-D optical coherence tomography imaging and OptiMedica’s pattern scanning technology. It includes a liquid optics interface for stability and an integral guidance mapping system to deliver precise femtosecond pulses.

The Catalys has been installed in more than 20 ophthalmic practices in seven countries since its international launch in November 2011 and its U.S. launch in February 2012. It has been used to perform more than 3,000 laser cataract procedures, according to the release.

Article updated: September 5, 2012.