Saint Petersburg, Florida (PRWEB) August 24, 2015
Lenstec, Inc.—an established medical device manufacturer of technologically advanced implantable lenses for treating vision disorders—today announced the start of an FDA trial in support of gaining FDA clearance for its Segmented Bi-focal lens (SBL-3).
The SBL-3 is designed to provide near, intermediate and distance vision following cataract removal. The SBL-3 is the only bi-focal lens available in quarter diopter power increments for the distance vision segment of the lens, and it has a +3 add portion for near vision segment. The SBL-3 is implanted via the standard small incision surgical technique.
The SBL-3 is currently approved in Europe, China, Korea, Taiwan, and some Latin American and Middle Eastern markets. The SBL-3 has experienced rapid and successful results in the global presbyopia market over the last two years.
Lenstec’s high precision manufacturing process makes it possible to produce lenses in 0.25 diopter increments (compared to the industry standard 0.5 diopter powers) thereby providing physicians with added precision in achieving improved visual outcomes for their patients.
“Lenstec is thrilled to begin the SBL-3 trials for FDA clearance to provide this unique lens to US ophthalmologists and their patients,” said George Wiseman, Vice President of Sales and Marketing.
“This is the first and most important requirement in the FDA process. Lenstec looks forward to completing this critical phase with the goal of receiving FDA approval for the first Segmented Bi-focal lens in the U.S. market,” said John Clough Founder/CEO Lenstec Inc.
Lenstec is a leading designer and manufacturer of intraocular lenses (IOLs) to treat patients with a range of vision disorders. Founded in 1992, the company is dedicated to advancing vision technologies for Ophthalmic Surgeons and their patients worldwide. More information about Lenstec is available at http://www.lenstec.com.