Berlin-Bausch & Lomb introduces the fourth generation of the only FDA-approved accommodating intraocular lens (Crystalens HD) in Europe at the annual meeting of the European Society of Cataract and Refractive Surgeons.
Berlin-Bausch & Lomb introduces the fourth generation of the only FDA-approved accommodating lens (Crystalens HD) in Europe at the annual meeting of the European Society of Cataract and Refractive Surgeons.
The lens, which received CE mark approval in August, was launched in the U.S. market in July and supercedes a previous generation lens (Crystalens Five-O model).
The optic of the HD lens provides an enhanced depth of focus designed to improve near vision without compromising intermediate or distance vision, the company said. The lens does this without inducing increased undesirable dysphotopsia or night vision symptoms, according to the company.
In the FDA study, the lens was implanted in 125 primary eyes of patients who had 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, said the company in a prepared statement. Of the 67 subjects who were within ± 0.50 D of intended target, 80% achieved J2 or better at 4 to 6 months, according to the company.
“The availability of the lens represents a major addition to our European IOL platform, now able to serve the growing demand for presbyopia solutions,” Mike Riding, vice president, surgical/Europe, Middle East, and Africa, Bausch & Lomb.
The initial limited launch of the lens in Europe will be followed by a complete rollout planned for the second quarter of 2009, the company said.
Additionally, Bausch & Lomb launched a dynamic rotational eyetracking system (Zyoptix Advanced Control Eyetracking Technology [ACE]).
Designed to improve patient safety, the system tracks and simultaneously adjusts the ablation pattern for the entire duration of the treatment, according to the company. The system also has the capability to track and simultaneously compensate for static rotational movement, pupil shift, saccadic movement in the x and y plane, and movement along the z plane for more predictable and accurate outcomes. The system incorporates fully automated iris recognition.
The company also announced that it intends to form a joint venture focused on the laser vision correction industry with 20/10 Perfect Vision AG. The joint venture will combine the refractive eye surgery assets of both businesses. The transaction is expected to close by the end of 2008.