ALISO VIEJO, CALIF. — Bausch + Lomb announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market the Crystalens® AO in quarter diopter steps in the United States. The Crystalens accommodating intraocular lens (IOL) was first approved by the FDA in November 2003. Bausch + Lomb made the announcement today on the heels of the recent New Technology IOL (NTIOL) classification by CMS. The Crystalens AO is the fifth generation of the only FDA-approved accommodating lens.
Quarter diopters will be available for the Crystalens AO for the models AT50AO and AT52AO in the ranges of 18-22. Bausch + Lomb expects to have a wider dioptric range available by the end of the year. “Quarter diopter steps for the Crystalens® Five-0 and HD have been enthusiastically accepted by surgeons, so we have now added them to the AO model. We still remain the only presbyopic channel lenses available in the U.S. in quarter diopter steps and the only presbyopic lens with NTIOL status,” said Tom Frinzi, vice president of Global Commercial Operations, Bausch + Lomb Surgical. The company will begin shipping the Crystalens AO in the additional diopter steps on May 17, 2010.
“The approval of Crystalens AO in quarter diopters is Bausch + Lomb’s contribution to the best possible outcomes for our surgeons and patients,” said Amy Jacobs, worldwide marketing director, Crystalens. “We are very proud of the difference that Crystalens is making in the lifestyle of cataract patients.”
Approximately 3 million cataract surgeries are performed in the U.S. every year. A cataract is a clouding on the normally clear lens in the eye. When a cataract forms, the natural lens in the patient's eye can be replaced by an intraocular lens. Research indicates that only a small fraction of people realize that not all intraocular lenses are the same. The research also indicates that a number of patients are willing to pay a little extra money in order to get the best quality vision.
Crystalens is the only FDA-approved accommodating intraocular lens. Unlike the standard cataract replacement lenses, Crystalens is designed to not only eliminate the patient's cataract but also to give patients full range of vision so that they can see near, far and everything in between. Many Crystalens patients hardly, if ever, need to wear their glasses or contacts again.
For more information about the Crystalens, please visit www.crystalens.com or call 1.877.7.SEEBETTER.
About Bausch + Lomb
Bausch + Lomb is dedicated to bringing visionary ideas to eye health. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. 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 more than 10,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.
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