Newest generation of Crystalens receives FDA approval

Aliso Viejo, CA-Bausch & Lomb has received FDA approval to market the fourth-generation of the only FDA-approved accommodating lens(Crystalens HD). The lens was first approved in November 2003.

The surface of the new lens has been shaped to enhance the depth of focus with a proprietary optical modification. Theenhanced optic provides an increased depth of focus designed to improve near vision without compromising intermediate ordistance vision. The lens does this without inducing increased dysphotopsia or night-vision symptoms, according to thecompany.

In the FDA study, the lens was implanted in a total of 125 primary eyes of patients with a visually significant cataract,less than 1 D of corneal astigmatism, and the potential for best-corrected visual acuity of 20/25 or better in both eyes. Ofthese patients, 80% reported vision at J2 or better at 4 months.

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

Surgeons will be instructed to continue to use the same surgical protocols for the new lens as in the past, said Bausch &Lomb officials in a prepared statement. The company said that it will begin shipping the new lens the week of July7.