Multifocal cataract implant lens Tecnis approved for use: Abbott

Tecnis, a multifocal lens for cataract patients developed by Abbott Laboratories, has been granted approval by U.S. Food and Drug Administration.

Tecnis is a multifocal 1-piece intraocular lens (IOL) for cataract patients with and without presbyopia. Presbyopia is 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.

Intraocular lenses are are synthetic lenses implanted in a patient’s eye after the removal of the natural lens that has become clouded by a cataract.

Conventional monofocal intraocular lenses are designed to focus primarily at one distance and do not correct presbyopia.

Tecnis multifocal 1-Piece intraocular lens is a pupil-independent, full diffractive presbyopia-correcting lens designed for optimal image quality at all distances under any lighting condition.

Its optic design gives patients superior near vision and reading speed compared to other presbyopia-correcting IOLs. Abbott said in a statement.

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,” stated Jim Mazzo, senior vice president, Abbott Medical Optics.

Tecnis has a patented wavefront-designed aspheric anterior surface designed to reduce average spherical aberration to essentially zero. It reduces chromatic aberration for better image quality.

Tecnis multifocal intraocular lenses 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 central one millimeter area of the lens creates a far image focus, therefore patients with abnormally small pupils should achieve, at a minimum, the prescribed distance vision under photopic conditions.

However, because this multifocal design has not been tested in patients with abnormally small pupils, it is unclear whether such patients will derive any near vision benefit, Abbott alerted.

Autorefractors may not provide optimal postoperative refraction of multifocal patients; manual refraction is strongly recommended.

In contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power. Care should be taken when performing wavefront measurements as two different wavefronts are produced (one will be in focus (either far or near) and the other wavefront will be out of focus); therefore incorrect interpretation of the wavefront measurements is possible.

The long-term effects of intraocular lens implantation have not been determined, so Abbott recommends postoperative monitoring of implanted patients on a regular basis.

Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants.

The intraocular pressure of implant patients with glaucoma should be carefully monitored postoperatively.

Emmetropia should be targeted as this lens is designed for optimum visual performance when emmetropia is achieved.

The intraocular lenses are intended to be placed in the capsular bag.

Abbott started shipping Tecnis multifocal 1-piece intraocular lenses in select markets and plans for full commercial shipments to begin in April 2010.

Abbott is a global health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company markets its products in more than 130 countries.