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BAUSCH + LOMB RECEIVES 510(K) CLEARANCE FOR CRYSTALSERT® 2.6 INJECTOR FOR CRYSTALENS®AO and TRULIGN® TORIC IOLS
New Crystalsert® Injector Allows for Small Incision, Smooth Delivery
BRIDGEWATER, New Jersey, JANUARY 2, 2018 – Bausch + Lomb, a leading global eye health company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Crystalsert® 2.6 injector (CI-26). Designed exclusively for use across the entire diopter range of Crystalens® AO and Trulign® toric intraocular lenses (IOLs), the CI-26 facilitates smooth and easy delivery through an incision as small as 2.6 mm1.
“The CI-26 Injector includes several enhancements designed to assist IOL delivery through a smaller incision,” said Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb. “Surgeons already know the benefits of our Crystalens® accommodating and Trulign® toric lenses, and we are happy to provide them with a smaller incision option to deliver these benefits to their patients.2-4”
The CI-26 features a smooth, oval tip shape, which allows for easy wound entry and helps prevent tissue snagging. The tip also features a straight delivery channel to reach the capsular bag without wound stretch. A haptic guide and modified plunger tip support the leading and trailing haptics during delivery.
“As a surgeon who relies heavily on the Crystalens® and Trulign® IOLs, I’m looking forward to having an injector for these lenses that enables smaller incision surgery while providing smooth wound entry during implantation,” said Mitchell Shultz, M.D., cataract, cornea, and refractive surgeon, from Shultz Chang Vision in Los Angeles, CA.
About Crystalens® AO and Trulign® toric
As the first and only FDA-approved accommodating IOL, the Crystalens® AO delivers an active range of clear vision for your cataract patients3,5. Crystalens provides excellent quality of vision over a more natural range, 2,3,5 exceptional contrast sensitivity by focusing 100% of light, 100% of the time3,4 and minimal issues with halos and glare.3,4,5 Pseudophakic accommodation of up to one diopter is provided by the design of the Crystalens IOL5.
Trulign® toric was the first FDA-approved toric IOL in the U.S. that corrects for astigmatic and presbyopia with a broad range of vision. Providing a new direction for astigmatic and presbyopic cataract patients, the innovative Trulign® toric IOL features an advanced aspheric optic for exceptional visual acuity extending from mid-range to distance.
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.
References
1. Data on File. CI-26 V&V Design Review
2.Data on file, Bausch & Lomb Incorporated. Study 650.
3. Ang RE, et al. Prospective evaluation of visual outcomes with three presbyopia-correcting intraocular lenses following cataract surgery. Clinical Ophthalmology. 2013;7:1811-1823.
4. Pepose JS, Qazi MA, Davies J, et al. Visual performance of patients with bilateral vs combination Crystalens, ReZoom, and ReSTOR intraocular lens implants. Am J Ophthalmol. 2007;144(3):347-357
5. Crystalens® AO. Directions for Use. Bausch & Lomb Incorporated.
Crystalsert, Crystalens and TRULIGN are trademarks of Bausch & Lomb Incorporated or its affiliates.
© 2017 Bausch & Lomb Incorporated. CRS.0034.USA.17
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