FDA Approves Intraocular Lens for Use in Patients with Cataracts

More than 20 percent of Americans will have cataracts by the age of 65

FDA Approves Intraocular Lens for Use in Patients with Cataracts
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July 18, 2016

An intraocular lens (IOL) option providing vision relief may be on the way in for patients suffering with cataracts.

The Food and Drug Administration (FDA) has approved the Tecnis Symfony Extended Range of Vision IOL, the first IOL that provides cataract patients with an extended depth-of-focus. This helps to improve sharpness of vision at near, intermediate, and far distances.

"While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology," said Malvina Eydelman, in a written statement. Eydelman is the director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA's Center for Devices and Radiological Health. "The Tecnis Symfony Extended Range of Vision IOL provides a new option for patients that may result in better vision across a broader range of distances."

Cataracts are a common eye condition where the natural lens becomes clouded, impairing a patient's vision. According to the National Eye Institute, more than 20 percent of Americans will have cataracts by the age of 65, and the prevalence increases with age. In cataract surgery, the clouded natural lens is removed and replaced with an IOL.

Traditional monofocal IOLs have been limited to improving distance vision. The Tecnis Symfony IOL improves visual acuity at close, intermediate and far ranges and, therefore, may reduce the need for patients to wear contact lenses or glasses after cataract surgery.

The FDA's approval is based on a randomized clinical trial comparing 148 cataract patients implanted with the Tecnis Symfony IOL to 151 cataract patients implanted with a monofocal IOL. Of the patients implanted with the Tecnis Symfony IOL, 77 percent had good vision (20/25), without glasses at intermediate distances, compared to 34 percent of those with the monofocal IOL.

Patients implanted with the Tecnis Symfony IOL may experience worsening of or blurred vision, bleeding or infection. The device may cause reduced contrast sensitivity that becomes worse under poor visibility conditions such as dim light or fog. Some patients may experience visual halos, glare or starbursts. The device is not intended for use on patients who have had previous trauma to their eye.

The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics.