FDA Approves Bausch & Lomb Akreos(TM) Advanced Optics Aspheric Lens.
ALISO VIEJO, Calif. -- Bausch & Lomb announced today it has received U.S. Food and Drug Administration (FDA) approval to market the Akreos([TM]) Advanced Optics Aspheric Lens (model AO60) in the United States.
The Akreos AO Lens is a single-piece, foldable acrylic intraocular lens with a unique four-haptic design and aspheric optics designed to be aberration-free.(*) The lens is implanted with Bausch & Lomb's single-use AI-28 inserter, which enables single-handed insertion through an un-enlarged standard phaco incision.
The company expects to begin shipping the Akreos AO Lens to surgical facilities this month.
"I have been treating patients with the Akreos AO Lens for more than a year and a half in Canada and the single-piece four-haptic design allows for consistent post-op centration," said Rosa Braga-Mele, M.Ed, M.D., FRCSC. Dr. Braga-Mele serves as the director of the Cataract Unit and Surgical Teaching at Mt. Sinai Hospital in Toronto.
In the U.S., John Hunkeler, M.D., said, "The high quality aspheric optic, coupled with the Akreos biocompatible acrylic material will benefit my practice by providing excellent outcomes for my patients." Dr. Hunkeler is a clinical professor and former chairman of the Department of Ophthalmology at the University of Kansas and is in private practice in Kansas City, Mo.
"The Akreos AO Lens efficiently delivers visual quality and heightened contrast sensitivity in order to achieve high patient satisfaction. With this result, surgeons can be confident that they are using a technology that improves vision quality and will enhance the lifestyle of their patients," said Brendan Sheil, senior vice president, Bausch & Lomb Surgical.
The distinctive properties of the Akreos lens will serve as a pathway to microincision cataract surgery, enabling new lens technologies that can be inserted through smaller incisions. Surgeons in the U.S. will now have the opportunity to expand their acrylic lens experience by having access to the Akreos AO.
About Bausch & Lomb
Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs approximately 13,000 people worldwide. Its products are available in more than 100 countries. More information about the company can be found at www.bausch.com. More information about surgical products and services can be found at www.bauschsurgical.com.
*Clinical studies have not been conducted with the Akreos Advanced Optics Aspheric lens to assess the effect of the added aspheric surface to the parent lens model Akreos on spherical aberration, visual acuity and contrast sensitivity.
Akreos is a trademark of Bausch & Lomb Incorporated.
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|Date:||Sep 15, 2008|
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