Abbott announced that the Food and Drug Administration (FDA) has approved the Tecnis Symfony Intraocular Lenses for the treatment of cataracts. These are the first intraocular lenses (IOLs) to offer a full range of continuous high-quality vision after cataract surgery, and they lower the risk of presbyopia by helping patients focus on near objects. The FDA has also approved the Tecnis Symfony Toric IOL, a version for patients with astigmatism.
The Tecnis Symfony IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed. The Tecnis Symfony Toric IOLs, Models ZXT150, ZXT225, ZXT300 and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed.
The most commonly used IOL in cataract surgery is a monofocal lens, which only enables the patient to see at a distance; closer objects would be out of focus. The Symfony lens, however, was designed with features to enhance both the quality and range of vision.
The approval was based on data from a U.S. study (n=298) that compared Tecnis Symfony Lens to a Tecnis aspheric monofocal lens. Patients who received a Tecnis Symfony IOL experienced greater improvements in intermediate and near vision with similar distance vision vs. patients who received a monofocal lens. Also, patients in the Tecnis Symfony group were more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition compared to those in the monofocal group. The rate of adverse events did not vary among the two study groups.
Other clinical studies demonstrated Tecnis Symfony IOL to provide seamless, day-to-night vision, high-quality vision, and a low incidence of halo and glare.
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