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Home E-Weekly December 27, 2011

FDA Collaboration Seeks to Stem TASS

Published: December 23, 2011

The U.S. Food and Drug Administration has teamed up with other government agencies and professional organizations to track and stem outbreaks of toxic anterior segment syndrome (TASS), a rare inflammatory condition associated with cataract surgery.

The Proactive TASS Program (PTP) a partnership between the FDA, the Centers for Disease Control and Prevention and the American Academy of Ophthalmology, will include a joint FDA-AAO registry designed to collect information about the devices used in cataract surgery and patient outcomes following cataract surgery; standardized methods for testing the level of TASS-related contaminants in ophthalmic devices; and an agreement with the CDC to collect and transport samples from suspected TASS outbreaks to FDA's lab for analysis.

"As the baby boomers continue to age, the number of cataract surgeries will increase," says Malvina Eydelman, MD, of the FDA's Center for Devices and Radiological Health. "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."

Mark McGraw

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