Bausch & Lomb announced that it has 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 US.
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.
Dr. John Hovanesian was a principal investigator in the FDA study. He 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 100% of available light to a single point of focus in the eye, 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 is my lens of choice for presbyopia correction in patients with cataracts. The addition of quarter diopters will only enhance my ability to target and provide patients the best possible outcomes with the Crystalens HD.”
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. “Quarter diopter steps for the Crystalens 5-0 have been enthusiastically accepted by surgeons, so we have added them to the HD model. We still remain the only presbyopic channel lenses available in the US in quarter diopter steps,” said Mike Judy, vice president of Global Surgical Marketing.
The company will begin shipping the Crystalens HD in the additional diopter steps on July 16, 2009.
“The approval of Crystalens HD in quarter diopters is Bausch & Lomb’s contribution to the best possible outcomes for our surgeons and patients,” said Andy Corley, president of Bausch & Lomb Surgical. “We are very proud of the difference that Crystalens is making in the lifestyles of cataract patients.”