FDA clears B+L laser platform for lens fragmentation

Laval, Quebec-Bausch + Lomb has received 510(k) clearance from the FDA for its Victus femtosecond laser platform for laser-assisted lens fragmentation during cataract surgery.

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 laser platform offers various lens fragmentation patterns depending on the cataract grade and user preference, according to the company.

The laser platform is used in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea, for anterior capsulotomy during cataract surgery, and for the creation of cuts/incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatments, not for fragmentation of posterior subcapsular and cortical cataracts.

Bausch + Lomb has been installing the laser platforms in surgery centers globally since it received CE mark in November 2011 and the FDA clearances in July 2012.

“Bausch + Lomb has made great progress building out a comprehensive and competitive product portfolio for ophthalmic surgeons, and (the) lens fragmentation clearance on the (laser) platform further strengthens our offerings,” said Calvin Roberts, MD, chief medical officer, Bausch + Lomb.

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