Crystalens HD™ Receives FDA Approval

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 3:00 PDT

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Bausch & Lomb announced that it has received approval from the Food and Drug Administration (FDA) to market the Crystalens HD™ 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, vice president of global marketing - 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.

"If I were a patient having cataract surgery, I would want an IOL that projects a single point of focus and also provides a broad range of distance, intermediate and near vision. The Crystalens HD is the best available lens to achieve that goal," said Dr. Hovanesian. "There is no question that the HD will be my lens of choice for presbyopia correction in patients with cataracts."

Bausch & Lomb officials said that surgeons will be instructed to continue to use the same surgical protocols for the Crystalens HD as they have used in the past. The Company has said that it will begin shipping the Crystalens HD the week of July 7th.

About Crystalens HD

Crystalens HD is a product developed by Bausch & Lomb. To learn more about Crystalens HD, please visit http://www.crystalens.com.

About Bausch & Lomb

Bausch & Lomb is an eye health company dedicated to perfecting vision and enhancing life. Bausch & Lomb offers the world's most comprehensive portfolio of eye health products. The Company has one of the oldest, best known and most respected healthcare brands in the world. Bausch & Lomb offers a full suite of products in cataract and vitreoretinal surgery including intraocular lenses and delivery systems, phacomulsification equipment and other surgical instruments and devices.

Bausch & Lomb