MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals and patients of the request for recall
of all brands and sizes of Balanced Salt Solution (BSS) manufactured by
Cytosol Laboratories, Inc. because product lots were found to have elevated
and dangerous levels of endotoxin. BSS is a drug used by health
professionals to irrigate a patient's eyes, ears, nose and/or throat during
a variety of surgical procedures including cataract surgery. FDA has
received reports of a serious and potentially irreversible eye injury called
Toxic Anterior Segment Syndrome (TASS) which occurs when a contaminant, such
as endotoxin, enters the anterior segment of the eye during surgery and
causes an inflammatory reaction.  FDA has also received complaints relating
to injuries in over 300 patients who were given BSS manufactured by Cytosol
Laboratories The BSS products subject to the recall order were manufactured
by Cytosol Laboratories, Inc. for distribution under three labels:

"AMO Endosol" distributed by Advanced Medical Optics, Inc. (AMO), Santa Ana,
Calif.;
"Cytosol Ophthalmics" distributed by Cytosol Ophthalmics, Lenoir, NC; and
"Akorn" distributed by Akorn, Inc., Buffalo Grove, Ill.

Read the complete MedWatch 2006 Safety summary, including a link to the FDA
Press Statement, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Cytosol