Abbott Receives U.S. FDA Approval for New Cataract Multifocal Intraocular Lens
Abbott announced today it has received U.S. Food and Drug Administration (FDA) approval for the TECNIS Multifocal 1-Piece intraocular lens (IOL) for cataract patients with and without presbyopia.
Intraocular lenses are implanted in a patient's eye after the removal of the natural lens that has become clouded by a cataract. Conventional monofocal IOLs are designed to focus primarily at one distance and do not correct presbyopia, an age-related change in vision that occurs when the eye's natural lens can no longer adjust its focal length to allow clear vision at different distances.
The TECNIS lens has also received presbyopia-correcting IOL status by the Centers for Medicare and Medicaid Services (CMS), providing Medicare beneficiaries with the option to receive a TECNIS Multifocal 1-Piece lens for an additional fee as part of cataract surgery.
"With this approval, Medicare cataract patients have a new opportunity to enjoy near, intermediate and distance vision without needing glasses, with nearly 9 out of 10 patients reporting that they never wear glasses following surgery," said Jim Mazzo, senior vice president, Abbott Medical Optics. "As an added benefit, surgeons now have the clinical benefits and high patient satisfaction rates they have come to expect with the TECNIS Multifocal 3-Piece IOL in a next-generation, easy to insert, one-piece design." The TECNIS Multifocal 1-Piece IOL is a pupil-independent, full diffractive presbyopia-correcting lens designed for optimal image quality at all distances under any lighting condition. Its unique optic design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs.
Other features/benefits include:
-- Patented wavefront-designed aspheric anterior surface designed to reduce average spherical aberration to essentially zero
-- Reduction of chromatic aberration for better image quality
-- Next-generation, easy-to-insert one-piece design
"I look forward to incorporating the TECNIS Multifocal 1-Piece IOL into my practice for patients who desire spectacle independence," said Kerry Assil, M.D. "I've been extremely pleased with the pupil-independent performance of the prior design and anticipate the same inherent benefits will be demonstrated by the TECNIS Multifocal optic lens on the one-piece platform." TECNIS multifocal IOLs are indicated for primary implantation for the visual correction of adult patients with and without presbyopia in whom a cataractous lens has been removed and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag. Abbott has begun shipping TECNIS Multifocal 1-Piece IOLs in select markets and plans for full commercial shipments to begin in April 2010.