Bausch + Lomb’s Adjustable Chandelier Fiber for the Stellaris® PC Vision Enhancement System Receives FDA Clearance

Optimized Illumination and Adjustable Optic Fiber Tips Offer Excellent Visibility and Efficiency in the Eye During Vitreoretinal Procedures

Adjustable Chandelier Fiber Available in 23- and 25-Gauge Versions

FOR RELEASE THURSDAY, SEPTEMBER 17, 2015

BRIDGEWATER, NJ – Bausch + Lomb, a leading global eye health company, today announced that 510(k) clearance has been received from the U.S. Food and Drug Administration (FDA) for an adjustable chandelier fiber optic illuminator in 23- and 25-gauge versions, which has been designed specifically for the Stellaris^® PC Vision Enhancement System. The adjustable chandelier will deliver surgeons with uniform, diffused lighting and modifiable light control to help provide excellent intraocular visibility and efficiency during vitreoretinal procedures. “We are extremely pleased to have received clearance from the FDA for this unique adjustable chandelier fiber design,” said Ari Kellen, MD, Head of U.S. Eye Health, Bausch + Lomb. “This enhancement will provide surgeons a ‘hands-free’ form of endoillumination as well as a wide field of light and a very convenient adjustment control, leading to exceptional visualization and added flexibility during surgical procedures. The approval further illustrates Bausch + Lomb’s commitment to continuous investment in delivering new devices and enhancements to meet the ever evolving needs of our customers.” Surgeons may utilize the adjustable chandelier in a number of surgical procedures such as the facilitation of bimanual surgery when multiple instruments may be required. This affords superb versatility during surgery as well as to support particularly complex cases.

The chandelier works trans-scleral or integrates seamlessly with the Entry Site Alignment (ESA) valved cannulas. The device will also provide Stellaris^® PC users the following additional features including:

• Controlled Light Adjustment: Surgeons can easily fine-tune the degree of light in the eye without directly modifying the machine settings or breaking focus from the patient by adjusting the available slider.

• Adjustable Fiber: The flexible cable allows surgeons to manage light intensity for optimal illumination, without removing the fiber from the valved cannula. The optical fiber tip is designed to extend into the eye for a controlled yet minimal distance for optimal placement and illumination yet away from the lens.
  
  
• Secure Placement: The distal fiber is designed to friction fit within the valved cannula to prevent inadvertent disconnection during surgery, yet allows controlled removal and relocation.
  
  
• 90° Distal Curvature: Designed to facilitate placement around the eye.
  
  

“The clearance of the adjustable chandelier will allow surgeons even more versatility when using the Stellaris PC system,” said Robin Ross, MD, from the University of Michigan Kellogg Eye Center in Brighton, MI. “The fibers are flexible and provide excellent illumination, which is especially important during complex, bimanual cases. I can quickly relocate, dim or brighten the light with the slide of the finger in the sterile field, which is especially helpful when operating alone without the need of an assistant, so I can continue to focus solely on the patient.”

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.  
© 2015 Bausch & Lomb Incorporated.