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.