FDA Approves Marketing of Crystalens HD(TM) in Quarter Diopter Steps by Bausch & Lomb in the United States

July 14, 2009

Dr. Ari Weitzner

Bausch & Lomb announced yesterday that it received approval from the Food and Drug Administration (FDA) to market the Crystalens HD™ 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 in conjunction with the celebration of the Crystalens HD first anniversary of approval. The Crystalens HD is the fourth generation of the only FDA approved accommodating lens and is the number one selling presbyopic channel lens in the U.S.

The surface of the Crystalens HD has been shaped to enhance the depth of focus with an optical modification. The enhanced optic provides an increased depth of focus which is designed to improve near vision without compromising intermediate or distance vision.

Quarter diopters will be available for the Crystalens HD for the models HD500 and HD520 in the ranges of 18-22. Bausch & Lomb expects to have the diopters available in a wider range by the end of the year.

The company will begin shipping the Crystalens HD in the additional diopter steps on July 16, 2009.

The availability of quarter diopters is just one distinction that Crystalens enjoys. Other Crystalens advantages include:

Crystalens is the only FDA-approved accommodating lens in the U.S.;
Unlike standard IOLs, Crystalens can treat both cataracts and presbyopia;
Crystalens is designed to flex like the eye’s natural lens, so patients can see near, far and everywhere
in between;
No other replacement lens comes closer to mirroring the natural focusing ability of the eye;
It can even reduce or eliminate the need for glasses during most activities.