The newly cleared laser is designed to incise the cornea to create a disc-shaped piece of tissue that is surgically removed to shape the cornea and correct nearsightedness, according to the FDA.
“This approval expands the surgical treatment options available to patients for correcting nearsightedness,” FDA Center for Devices and Radiological Health ophthalmic and ear, nose and throat devices division director Dr. Malvina Eydelman said in a press release.
Approval came with support from a clinical study which reported stable vision correction at 6 months in 328 patients, with all but one reporting visual acuity of 20/40 or better and 88% reporting visual acuity of 20/20 or better.
Complications during surgery in the trial included difficulty removing the corneal tissue and loss of suction to keep the laser aligned with the eye. Post-surgery complications included debris at the site of tissue removal, dry eey, moderate to severe glare and moderate to sever halos.
In July, Carl Zeiss Meditec said it tapped James Mazzo as the global president of its ophthalmology business as well as managing the entire company’s U.S. sales and service center.
Mazzo comes from a 3-year run as president and CEO at AcuFocus, where he led the the company to FDA approval for its Kamra inlay. AcuFocus tapped Alan Waterhouse to operate as Prez & COO and Dr. William Link as board chair as Mazzo steps away.
The post FDA approves Carl Zeiss Meditec’s VisuMax Femtosecond laser appeared first on MassDevice.
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