Surgical Solution Recalled

Robert Blanchard

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I read with interest notice of a recent recall, because it wasn't clear what problem the product was causing. The recall pertained to an estimated 1 million units of balanced salt solution distributed between December 2003 and December 2005 under the brand names AMO Endosol (Advanced Medical Optics), Cytosol Ophthalmics (Cytosol Ophthalmics), and Akorn (Akorn Inc). The US Food and Drug Administration (FDA) requested the recall of all brands and sizes of balanced salt solution (made by Cytosol Laboratories, Inc), due to the presence of elevated endotoxin levels in some lots. The recall notice only tell us that there have been many reported cases of problems, including toxic anterior segment syndrome. I did a little check and it turns out this prodcut is often used for irrigation during eye surgery and it can set up this toxic reaction. The toxic reaction in some cases can be quite severe.

Severe TASS can do real damage:

It can permanently damage the corneal endothelium.
It can cause profound cystoid macular edema that will not resolve.
Patients may have a permanently dilated fixed pupil. "If you have a fixed dilated pupil the first operative day, at least a third of the time that pupil will never recover," Dr. Olson said.
Patients may have permanent damage to the trabecular meshwork, leading to resistant glaucoma that requires multiple surgical procedures. "If the pressure is real high, you have a 50-50 chance of chronic glaucoma," Dr. Olson said.