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Crystalens HD(TM) Receives FDA Approval
Date:6/30/2008

Newest Version of the Only FDA Approved Accommodating Lens Designed to

Further Improve Near Vision

ALISO VIEJO, Calif., June 30 /PRNewswire/ -- Bausch & Lomb announced today that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD(TM) in the United States. Crystalens accommodating intraocular lens (IOL) was first approved by the FDA in November 2003. The Crystalens HD is the fourth generation of the only FDA approved accommodating lens.

The surface of the Crystalens HD has been shaped to enhance the depth of focus with a proprietary optical modification. The enhanced optic provides an increased depth of focus which is designed to improve near vision without compromising intermediate or distance vision. The HD lens does this without inducing increased undesirable dysphotopsia or night vision symptoms.

A total of 125 primary eyes were implanted with the Crystalens HD in patients who had a visually significant cataract, less than 1 diopter of corneal astigmatism, and the potential for best corrected visual acuity (BCVA) of 20/25 or better in both eyes. Of these patients, 80% reported vision at J2 or better at four (4) months.

"Extensive market research has clearly indicated that patients and surgeons alike are asking for a truly accommodating IOL as their choice of lens. With these results, where patients reported getting one more line of near vision, we are coming ever closer to meeting the desired need for an optic that does provide truly good near vision without compromising the quality of vision at intermediate or distance," said Michael Judy, Chief Marketing Officer at Bausch & Lomb Surgical.

Dr. John Hovanesian was a Principal Investigator in the FDA study. Dr. Hovanesian serves as Clinical Instructor at the Jules Stein Eye Institute, UCLA in California and is in private practice at Harvard Eye Associates in Laguna Hills, California.

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SOURCE Bausch & Lomb
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