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FDA Collaboration to Monitor Rare Eye Condition Associated With Cataract Surgery
Date:12/20/2011

s will increase," said Malvina Eydelman, M.D., director of the Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices within the Office of Device Evaluation in CDRH. "Information collected by the program will lead to the earlier investigation of national TASS outbreaks and determination of whether a medical device is the source of the outbreak."

The program includes:

  • collaboration between the FDA and the AAO on a registry designed to collect information about the devices used in cataract surgery and patient outcomes following cataract surgery
  • standardized methods to test the level of TASS-related contaminants in ophthalmic devices
  • an agreement with the CDC to collect and transport samples from suspected TASS outbreaks to FDA's lab for analysis.

Improved coordination and communication will be emphasized in the program.

"CDC investigation of outbreaks can be helpful to other government agencies working on patient safety," said Judith Noble-Wang, Ph.D., lead microbiologist of the CDC's Division of Healthcare Quality Promotion. "The program is an additional way for us to share information designed to protect patients with our colleagues at FDA."

TASS usually occurs within 48 hours after cataract surgery on the front portion of the eye that includes the cornea, iris, lens, and the fluid-filled space between the lens and the cornea (anterior chamber). Symptoms include blurry vision and redness resulting from swelling of the cornea and a build up of white blood cells, protein, or fibrin deposits in the anterior chamber. While many cases resolve in a few weeks without treatment, some people can develop serious complications leading to additional surgeries and vision loss.

It is estimated that 1 in every 6 people over 40 in the United States have a cataract. More than 3 million cataract surgeries are performed nationwide every year.

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SOURCE U.S. Food and Drug Administration
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