The approval is granted for Tecnis Symfony Toric IOL to be used for people with astigmatism.
Tecnis Symfony lenses are claimed to be only lenses in the US that can offer a range of continuous quality vision following cataract surgery and reduce the effects of presbyopia to focus on near objects.
The approval was based on results of the US pivotal study, which compared the Tecnis Symfony lens to a Tecnis aspheric monofocal lens in 298 patients.
According to the company, Tecnis Symfony IOL achieved greater improvements in intermediate and near vision when compared with patients in the monofocal group.
Tecnis Symfony Toric IOLs, including models such as ZXT150, ZXT225, ZXT300 and ZXT375, will be used for primary implantation for the visual correction of aphakia.
They can also be used 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 lenses enable patients to see objects sharply and clearly at near, intermediate and far away distances, and points in between, said the company.
Symfony lenses have been approved in around 50 countries across the globe.
Abbott vision business senior vice president Thomas Frinzi said: "Abbott is focused on improving people's vision and their lives by helping them stay healthy and active.
“Symfony offers patients, including those with astigmatism, an option for crisp, clear vision at all distances.”
Image: Abbott global headquarters in Illinois. Photo: courtesy of Abbott.
