On January 2, 2009, the U.S. Food and Drug Administration (FDA) announced an urgent, nationwide recall of Healon D, manufactured by Advanced Medical Optics, Inc. The ophthalmic viscosurgical device has been recalled due to complaints of post-operative intraocular inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS).
If you or somebody you know has developed eye inflammation or TASS after having eye surgery where Healon D was administered, you should contact us immediately. You may be entitled to compensation and we can help.
This recall of Healon D is limited specifically to lot number UD30654.
According to AMO, they have received 66 adverse event reports associated with the recalled product(s). Tests of lot number UD30654 revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.
What is Toxic Anterior Segment Syndrome (TASS)?
TOXIC ANTERIOR SEGMENT SYNDROME (TASS) is a rare, potentially devastating complication of routine intraocular surgery that occurs when a noninfectious toxic agent enters the anterior segment of the eye, causing an inflammatory reaction.
SEVERE CASES OF TASS can cause permanent harm, and if symptoms still are present after six weeks, the eye is not likely to recover.
EARLY DIAGNOSIS AND TREATMENT are effective in preventing permanent damage, but often TASS is mistakenly diagnosed as infectious endophthalmitis for which treatment is completely different.
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