Cataract Surgery Problems With TASS Result in FDA Monitoring Program

Federal health officials have announced a new monitoring program for problems with cataract surgery, aimed at preventing a rare, inflammatory condition linked to contaminated medical devices. 

The FDA, the U.S. Centers for Disease Control and Prevention (CDC), and the American Academy of Ophthamology (AAO) say a side effect of cataract surgery known as Toxic Anterior Segment Syndrome (TASS) is a growing problem that has affected hundreds of patients since 2000.

As a result, they announced the launch of the Proactive TASS Program (PTP) on December 20, which will try to combat the prevalence of TASS.

TASS appears to be caused by specific contaminants that can present in ophthalmic devices used in eye surgery. It causes blurry vision, redness and other problems from swelling of the eye shortly after cataract surgery, usually within 48 hours. In some cases it can lead to serious complications that could result in vision loss and require additional surgeries to treat.

The FDA’s Center for Devices and Radiological health (CDRH) confirmed through studies that TASS was linked to medical devices for eye surgery. The CDRH has developed new testing methods that health officials hope will result in new guidelines for makers of medical devices used in eye surgeries.

The PTP will mean that the FDA and AAO will collaborate on a registry that looks at data from medical devices used in eye surgeries and patient outcomes. There will also be standardized tests for TASS-related contaminants in medical devices and the CDC will collect and transport samples from suspected TASS outbreaks to the FDA for analysis.

There are more than three million cataract surgeries performed in the U.S. each year. Approximately one in six people over the age of 40 in the U.S. have a cataract, the FDA estimates.

There have been a number of recalls over the last several years related to medical devices that carried TASS contaminants. In January 2009, the FDA issued a Class I medical device recall for one lot of  Advanced Medical Optics, Inc. (AMO) Healon D ophthalmic viscosurgical devices (OVDs) used to maintain space in the eye during cornea transplant eye surgery and other procedures. That device was linked to 66 cases of TASS eye problems.