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FOR RELEASE 2/13/2013, Wednesday

VICTUS™ Femtosecond Laser Platform from Bausch + Lomb Technolas Receives 510(k) Clearance from FDA for Arcuate Incision Procedure

Advanced Laser Technology Allows More Precise Surgical Results1,2,3

ALISO VIEJO, CA & MUNICH, GERMANY — Bausch + Lomb, the global eye health company, announced today that its VICTUS™ Femtosecond Laser Platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the creation of penetrating arcuate cuts/incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts/incisions in the cornea. The VICTUS Femtosecond Laser Platform, capable of supporting cataract and corneal procedures on a single platform, offers significant benefits over manual cataract surgery techniques.1,2 Specifically for arcuate incisions, the procedure offers ophthalmic surgeons a higher degree of precision.3

Bausch + Lomb Technolas (Technolas Perfect Vision GmbH) has been installing VICTUS systems in leading surgery centers globally since it received the CE mark in Europe in November 2011 and U.S. FDA clearance in July 2012. Today, the platform is approved for the creation of a corneal flap in patients undergoing LASIK surgery and anterior capsulotomy during cataract surgery, as well as penetrating arcuate incisions in the US. In Europe, the VICTUS platform is approved for the aforementioned procedures as well as INTRACOR and lens fragmentation. 

“With the additional FDA clearance in the U.S. for arcuate incisions, physicians can now perform multiple sight-enhancing procedures on patients using the VICTUS platform,” said John Barr, executive vice president and president, Bausch + Lomb Global Surgical. “This clearance enhances our already comprehensive offering in cataract and refractive surgery and makes VICTUS one of the most capable femtosecond lasers currently cleared for use in the U.S.” 

“Bausch + Lomb Technolas is committed to delivering meaningful technological innovations in ophthalmic laser-surgery that can help improve patient outcomes and quality of life,” said Kristian Hohla, Ph.D., president of Bausch + Lomb Technolas. “We are working to gain additional clearances in markets around the world, to maximize use of all of the capabilities of the VICTUS laser in cataract and refractive procedures and speed adoption of this versatile platform.”

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 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 is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, NY, and employs roughly 11,000 people worldwide. Its products are available in more than 100 countries. More information is available at www.bausch.com.

REFERENCES  

1. Reddy KP. Evaluation of the Precision and Predictability of Anterior Capsulotomy using a Femtosecond Laser. Presented at: The Annual Meeting of the American Academy of Ophthalmology (AAO); October 22 - 25, 2011; Orlando, Florida.
2. Reddy KP. Investigation into the precision and accuracy of femtosecond laser cataract surgery. Presented at: The Annual Meeting of the European Society of Cataract and Refractive Surgeons (ESCRS); September 8-12, 2012; Milan, Italy.
3.  Soong HK, Malta JB. Femtosecond lasers in ophthalmology. Am J Ophthalmol. 2009 Feb;147(2):189-197.e2.

®/™ are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2013 Bausch & Lomb Incorporated.

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News Media Contacts:
Jeanie Herbert
Global Surgical Communications, Bausch + Lomb
(949) 521-7948, (714) 325-3584 (mobile) or jeanie.herbert@bausch.com 

Tad Heitmann
BioComm Network on behalf of Bausch + Lomb
(714) 273-2937 or theitmann@BioCommNetwork.com

Lindsay Brooks
Medical Communications, Bausch + Lomb Technolas
+44 7825 769 007 (mobile) or lindsay.brooks@bausch.com