A Medical Device Daily
Bausch & Lomb Surgical (Aliso Viejo, California) said it has received FDA approval to market the Crystalens HD in the U.S. 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 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. 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 4 months.
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.
Bausch & Lomb is an eye health company.