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Multifocal lens receives FDA approval, presbyopia-correcting IOL status from CMS
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ABBOTT PARK, Ill. — Abbott has received U.S. Food and Drug Administration approval for its Tecnis multifocal one-piece IOL for use in cataract patients with and without presbyopia, the company announced in a press release.
In addition, the Centers for Medicare and Medicaid Services granted the lens presbyopia-correcting IOL status, a designation that will allow Medicare beneficiaries to receive the lens for an added fee as part of their cataract surgery, according to the release.
Designed for optimal image quality at all distances and under all light conditions, the Tecnis multifocal one-piece IOL is a pupil-independent, full-diffractive, presbyopia-correcting lens that offers enhanced near vision and reading speed. Featuring reduced chromatic aberration for better image quality, the wavefront-designed aspheric anterior surface is capable of reducing average spherical aberration to "essentially zero," the release said.
"With this approval, Medicare cataract patients have a new opportunity to enjoy near, intermediate and distance vision without needing glasses, with nearly nine out of 10 patients reporting that they never wear glasses following surgery," Jim Mazzo, senior vice president of Abbott Medical Optics, said in the release. "As an added benefit, surgeons now have the clinical benefits and high patient satisfaction rates they have come to expect with the Tecnis multifocal three-piece IOL in a next-generation, easy to insert, one-piece design."
Abbott has already begun shipping the lens in certain markets and plans to commence full commercial shipments in April.
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