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FDA approves Tecnis Symfony IOL for cataracts
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The FDA has approved the Tecnis Symfony IOL for the treatment of cataracts, Abbott announced in a press release. The approval includes the Tecnis Symfony Toric IOL for people with astigmatism.
The Symfony IOLs are the first extended range of vision IOLs approved in the U.S., providing full range of vision after cataract surgery while “mitigating the effects of presbyopia by helping people focus on near objects,” the release said.
The Tecnis Symfony IOL model ZXR00 is indicated for cataract patients for “primary implantation for the visual correction of aphakia in adult patients with less than 1 diopter of pre-existing corneal astigmatism,” the release said.
Toric models ZXT150, ZXT225, ZXT300 and ZXT375 are indicated for cataract patients 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,” the release said.
The Symfony IOLs are already approved in more than 50 countries. The U.S. approval is based on study results that compared the Symfony IOL to the Tecnis aspheric monofocal IOL. The Symfony group achieved a greater improvement in intermediate and near vision while maintaining similar distance vision compared to the monofocal group. Results showed that patients in the Symfony group were more likely to achieve reduced overall spectacle wear and high overall visual performance in any lighting condition, according to the release.
Both models are intended for capsular bag placement only.
Perspective
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John A. Hovanesian, MD, FACS
The FDA approval of Abbott's Symfony lens offers U.S. surgeons a brand new category of advanced IOL — one in which we offer an extended range of vision without the loss of intermediate vision that can occur with high-add multifocals. Because these lenses have proven themselves to be very well tolerated by patients, they will likely appeal to many patients who are not candidates for traditional multifocals but who want more range of vision than any monofocal lens can offer. Fortunately, the FDA simultaneously approved the toric versions of this lens, allowing us to correct patients both with and without astigmatism. I am really looking forward to using this lens.
Perspective
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Eric D. Donnenfeld, MD
The FDA approval of the Symfony extended focus IOL is an important opportunity for our patients who are interested in reduced dependence or elimination of the need for glasses at both distance and near. The Symfony differs from previous multifocal IOLs, which are really bifocal lenses, in that it provides a continuous range of vision by spreading out light along a range, rather than splitting it between two distinct points. Symfony is also available as a toric IOL as well. The lens also provides exceptional quality of vision at distance with reduced glare and halo that in the FDA trial was not that different from the monofocal IOL. In my experience from the FDA trials, the Symfony IOL is also more forgiving with residual refractive error, particularly hyperopia and astigmatism. The quality of vision is accomplished by dramatically reducing chromatic aberration as well as optimizing negative spherical aberration. Symfony is dramatically more patient-friendly than previous generations of presbyopia-correcting IOLs, and that makes it a surgeon-friendly lens, too, because it gives us all the opportunity to provide our patients with excellent quality of vision with a lower risk of dissatisfaction.
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