FDA Requests Saline Solution Recall

February 2006

Cytosol Laboratories Inc. has been asked by the Food and Drug Administration (FDA) to recall their saline solution used in cataract surgery. Over 300 reports of patient injuries prompted the FDA to make the request.

Patients who used Cytosol’s balanced salt solution were diagnosed with Toxic Anterior Segment Syndrome (TASS), an inflammation that could lead to permanent damage if not treated. The FDA told doctors, hospitals and consumers to stop using the solution because of contamination of high levels of endotoxin, a bacterial poison that causes fever, shock, blood pressure changes and other circulatory problems.

Around one million units of the solution were sold last year. Besides cataract surgery, the solution is also used for irrigating noses, ears and throats during surgical procedures.

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