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BioComm Network, Inc., on behalf of Bausch + Lomb
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BAUSCH + LOMB RECEIVES 510(k) Clearance from FDA on New 3.3 SOFTWARE for VICTUS® FEMTOSECOND LASER

BRIDGEWATER, New Jersey, Oct. 24, 2017 – Bausch + Lomb, a leading global eye health company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new 3.3 software package as well as new hardware for the VICTUS® femtosecond laser platform, which together are designed to enhance the VICTUS® user experience.

“VICTUS® has long been one of the most comprehensive and versatile femtosecond laser platforms available,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb. “The new software and hardware features combine to make the VICTUS® experience more user-friendly than ever before.”

3.3 Software Features

The VICTUS® 3.3 software features a new option for capsulotomy and lens fragmentation centration, providing surgeons with the choice to center the procedure on the pupil, the limbus, the lens apex or other positions as defined by the surgeon. Automatic pupil centration for the creation of corneal flaps is also included. These features eliminate the need for manual positioning, thus contributing to the precision of the treatment.

Another feature of the new software is the introduction of the grid lens fragmentation pattern, which provides surgeons with additional options to optimize their individual phacoemulsification technique.

Finally, the system’s startup diagnosis and pre-selection of its startup mode has been enhanced to improve usability and work flow as well as facilitate service and maintenance of the system.

New Hardware Features

In addition to the new software, VICTUS® now features a new S60 bed, which swings out further away from the laser, making it easier to get patients in and out during the procedure, helping to simplify workflow by allowing the phacoemulsification procedure to be completed on the same bed.

“As a VICTUS® user, I appreciate the platform’s versatility and breadth of offerings, as well as
Bausch + Lomb’s commitment to hearing customer feedback and innovating to meet our needs,” said Mitchell Schultz, M.D., cataract, cornea and refractive surgeon from Shultz Chang Vision in Los Angeles, CA. “I expect the new software and hardware features to have a significant positive impact on my user experience, and I’m looking forward to taking advantage of them in my practice.”

To learn more about the VICTUS® femtosecond laser platform, visit: http://www.victuslaser.com/.   

About the VICTUS® Femtosecond Laser
Bausch + Lomb has been installing VICTUS® platforms in leading surgery centers globally since it received CE mark in November 2011 and the FDA clearances in July 2012. To date, VICTUS® has multiple FDA clearance, including the creation of a corneal flap in patients undergoing LASIK surgery, anterior capsulotomy during cataract surgery, penetrating arcuate cuts/incisions in the cornea and laser-assisted lens fragmentation during cataract surgery. The VICTUS® platform has received additional CE marks including lamellar keratoplasty, penetrating keratoplasty and the creation of intrastromal channel incisions for intracorneal ring segments.
The versatile VICTUS® femtosecond laser platform offers an Advanced Swept Source OCT imaging system, which boasts high resolution, real-time imaging of the entire procedure and can be used to drive incision depth and detail the architecture of arcuate incisions. Its curved patient interface and intelligent pressure sensor provide the surgeon with full control during the entire procedure.

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 Femtosecond Lasers
Femtosecond lasers emit optical pulses of extremely short duration in the domain of femtoseconds, as short as one-quadrillionth of a second. These ultra-short pulses do not transfer heat or shock to the material being cut and can make surgical incisions with extreme precision. The technology was developed in the early 1990s at the University of Michigan Engineering Center. The first commercial platform was introduced in 2002 and the original approval was for flap creation during LASIK surgery. Recent platform approvals have been expanded to include additional corneal/therapeutic procedures and cataract applications.

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 with products available in more than 100 countries. 

VICTUS is a trademark of Bausch & Lomb Incorporated or its affiliates.
© 2017 Bausch & Lomb Incorporated. VCT.0063.USA.17