Bausch + Lomb’s Stellaris® PC Vision Enhancement System Receives 510(k) Clearance for Integrated 532nm Laser

FOR RELEASE 3/24/2014, Monday

Bausch + Lomb’s Stellaris® PC Vision Enhancement System Receives 510(k) Clearance for Integrated 532nm Laser

Additional Capability Enhances Comprehensive Surgical Platform

FOR RELEASE DAY OF MONDAY, MARCH 24, 2014  

BRIDGEWATER, NJ – Bausch + Lomb, a leading global eye health company, today announced the Stellaris® PC Vision Enhancement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the integrated 532nm laser and software. With this new capability, the Stellaris PC now provides one of the most complete ophthalmic surgical systems for posterior segment, anterior segment and combined procedures.

“This updated technology is another demonstration of Bausch + Lomb’s unwavering commitment to continuous innovation and improvement that is inspired by the evolving needs of our customers and the patients they serve,” said Cal Roberts, Chief Medical Officer, Bausch + Lomb. “To address the clinical, efficiency, and value requirements of the ophthalmic surgeon, the Stellaris PC now offers even greater procedural choice and more opportunities to improve surgical outcomes, from the lens to the retina, on a single, integrated fully-capable system.”

With this advance, the Stellaris PC now offers the following advantages to surgeon’s facilities:

•    A fully integrated 532nm green laser, which is upgradable for existing Stellaris PC Vision Enhancement Systems, and connects within the sterile field.

•    A first of its kind wireless, dual linear foot pedal that features integrated laser control and improved design offering greater versatility and flexibility for procedural needs. The pedal and ergonomic foot rest improves comfort for longer procedures by reducing pitch.  An optional LIO foot pedal, cable and headset are also available.

•    A full portfolio of multi-function laser fibers that meet a wide range of procedural needs, including straight, curved, illuminated and aspirating probes with a soft tip for added security when working close to the retina.

•    A redesigned interface and laser control software that offers improved clarity, enhanced contrast, and ease of use for both surgeons and staff.

“The Stellaris PC’s intuitive and efficient design allows me to keep my mind on my patient; not the setup or functionality of the system itself,” said Victor Gonzalez, MD. “With the availability of the integrated laser and related enhancements, the Stellaris PC will become the most versatile tool in my practice for delivering excellent clinical outcomes with efficiency."

For more information on Stellaris® PC Vision Enhancement System, click here.

About Vitreoretinal Surgery
Vitreoretinal surgery is the treatment of disorders of the posterior segment, including the retina, vitreous and macula. Ophthalmic surgeons use specialized techniques, instruments and solutions to treat conditions that include retinal detachment, macular degeneration, diabetic retinopathy, and uveitis. Retinal and vitreous problems can cause severe loss of vision or even blindness. In some cases, surgery may be beneficial and - if done at the right time - might prevent severe loss of vision.

About Cataract Surgery
According to the World Health Organization, there are about 100 million people in the world today who are 80 years old or older. That number is expected to almost quadruple by 2050. Aging is the leading cause of eye diseases, such as cataracts. A cataract is a clouding of the normally clear lens in the eye. It also happens to be the leading cause of blindness in the world. According to the U.S. National Eye Institute, cataract surgery is one of the safest, most common and effective surgical procedures. Worldwide, over 20 million cataract surgeries are performed annually. Cataract surgery is a simple procedure during which the natural lens in the patient's eye is surgically replaced with an intraocular lens (IOL).

About Bausch + Lomb
Bausch + Lomb, a Valeant Pharmaceuticals International, Inc. company, is a leading global eye health organization that is solely focused on protecting, enhancing, and restoring people’s eyesight. Our core businesses include ophthalmic pharmaceuticals, contact lenses, lens care products, ophthalmic surgical devices and instruments. We develop, manufacture and market one of the most comprehensive product portfolios in our industry, which are available in more than 100 countries.

Stellaris is a trademark of Bausch & Lomb Incorporated or its affiliates.  
© 2014 Bausch & Lomb Incorporated

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News Media Contacts:
Kristy Guerra
Public Relations Product Manager, Bausch + Lomb
(585) 338-8095 or [email protected]

Tad Heitmann
BioComm Network, on behalf of Bausch + Lomb
(714) 273-2937 or [email protected]

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