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FDA Approves Intraocular Lens for Cataract Patients


On July 15, 2016, the FDA approved the first intraocular lens (IOL) that provides cataract patients with an extended depth-of-focus, which helps improve their sharpness of vision at near, intermediate and far 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.

 

The most common symptoms of a cataract are:

 

  • cloudy or blurry vision
  • colors seem faded
  • glare--headlights, lamps, or sunlight may appear too bright
  • a halo may appear around lights
  • poor night vision
  • double vision or multiple images in one eye (this symptom may clear as the cataract gets larger)
  • frequent prescription changes in your eyeglasses or contact lenses

 

“While IOLs have been the mainstay of cataract treatment for many years, we continue to see advances in the technology,” said Malvina Eydelman, M.D., 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.”

 

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 approval is based on a review of results from a randomized clinical trial comparing 148 cataract patients implanted with the Tecnis Symfony IOL to 151 cataract patients implanted with a monofocal IOL. The study evaluated visual acuity at near, intermediate, and far ranges; contrast sensitivity (the ability to distinguish small differences between light and dark); and adverse events for six months after implantation. 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. For near distances, patients with the Tecnis Symfony IOL were able to read two additional, progressively smaller lines on a standard eye chart than those with the monofocal IOL. Both sets of patients had comparable results for good distance vision.

 

As with any surgery, cataract surgery poses risks, such as infection and bleeding. 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 IOL is also available in four other models, which are indicated for the reduction of residual refractive astigmatism or imperfections in the curvature of the eye. The Tecnis Symfony Extended Range of Vision IOL is manufactured by Abbott Medical Optics, Inc. of Santa Ana, California.

 

See the FDA Announcement

 

See also Medical Law Perspectives, July 2014: Injuries Resulting From Laser Procedures: Risks for Physicians, Technicians, and Manufacturers

 

See also Medical Law Perspectives, March 2013: When Cataract Treatment Creates More Harm Than Cure: Malpractice Liability Issues

 

See the Medical Law Perspectives April 3, 2015, Blog: Contact Lens Not Subject to Recall But Manufactured in the Same Facility, and Having Same Material Defect, Could Not Be Basis for Manufacturer’s Liability

 

 

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