PRNewswire
Newest Version of the Only FDA Approved Accommodating Lens Designed to Further Improve Near Vision ALISO VIEJO, Calif., June 30
ALISO VIEJO, Calif., June 30 /PRNewswire/ -- Bausch & Lomb announced today
that it has received approval from the Food and Drug Administration (FDA) to
market the Crystalens HD(TM) in the United States. 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 a proprietary 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 four (4) months.
"Extensive market research has clearly indicated that patients and
surgeons alike are asking for a truly accommodating IOL as their choice of
lens. With these results, where patients reported getting one more line of
near vision, we are coming ever closer to meeting the desired need for an
optic that does provide truly good near vision without compromising the
quality of vision at intermediate or distance," said Michael Judy, Chief
Marketing Officer at Bausch & Lomb Surgical.
Dr. John Hovanesian was a Principal Investigator in the FDA study. Dr.
Hovanesian 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 a single point of focus 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
will be my lens of choice for presbyopia correction in patients with
cataracts."
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.
ABOUT CRYSTALENS HD
Crystalens HD is a product developed by Bausch & Lomb. To learn more about
Crystalens HD, please visit http://www.crystalens.com. The Crystalens(R) Call
Center is 1-888-393-6642.
ABOUT BAUSCH & LOMB
Bausch & Lomb is an eye health company dedicated to perfecting vision and
enhancing life. Bausch & Lomb offers the world's most comprehensive portfolio
of eye health products. The Company has one of the oldest, best known and most
respected healthcare brands in the world. Bausch & Lomb offers a full suite
of products in cataract and vitreoretinal surgery including intraocular lenses
and delivery systems, phacomulsification equipment and other surgical
instruments and devices. To learn more about Bausch & Lomb, visit
http://www.bausch.com