Litigation

FDA News: Healon D Recall

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

 AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.

Toxic Anterior Segment Syndrome (TASS) is an acute, sterile inflammation following generally uneventful cataract and anterior segment surgery.

One of the main factors in differentiating TASS from an infectious other condition is the rapid onset. Most patients with TASS will develop symptoms within 12 to 24 hours of the surgery. . Patients may show signs of diffuse corneal edema  and they may also show signs of iris atrophy  with pupillary abnormalities and eventual increased intraocular pressure.

The degree of damage caused by TASS depends on many factors, including the type and amount of substance introduced into the eye, the duration of exposure, and how quickly treatment begins. An especially acute form of TASS, called toxic endothelial cell destruction syndrome, predominantly affects the corneal endothelium,⁷ whereas toxic endophthalmitis or sterile endophthalmitis significantly affects the posterior segment.

Full post as published by Trial Lawyer Resource Center on January 02, 2009 (boomark / email).