Bausch + Lomb won new CE Mark approvals for its Victus laser platform, allowing the device maker to market the system for additional uses during cataract surgery.
In additional to corneal incision, European regulators approved 2 additional indications for Victus, green-lighting the system for use during full corneal transplant, or penetrating keratoplasty, and for incisions performed during device implants into the eye.
That means the Victus has E.U. approval for all the steps of laser-assisted cataract surgery and for certain incisions during Lasik treatments. The Victus device platform originally won CE Mark approval in November 2011 and FDA clearance in July 2012.
"With these additional CE approvals for corneal incisions, penetrating keratoplasty and intrastromal channel incisions for intracorneal ring segments on the Victus platform, Bausch + Lomb now offers the most versatile femtosecond laser system for cataract and refractive surgery in the European Union," B+L president Kristian Hohla said in prepared remarks.
That’s more good news for Bausch + Lomb, following a thumbs-up from FDA advisory panelists who agreed to recommend Trulign Toric, the company’s intraocular lens, despite a “strong minority opinion” that the safety and efficacy of the device may be in question.
The company was recently slammed with a Class I recall amid reports that its syringe components may break during injection.
