Multistate outbreak of toxic anterior segment syndrome, 2005.

Purpose: To present the findings of an outbreak of toxic anterior segment syndrome (TASS).

Setting: Six states, 7 ophthalmology surgical centers, United States.

Methods: Cases were identified through electronic communication networks and via reports to a national TASS referral center. Information on the procedure, details of instrument reprocessing, and products used during cataract surgery were also collected. Medications used during the procedures were tested for endotoxin using a kinetic assay.

Results: The search identified 112 case patients (median age 74 years) from 7 centers from July 19, 2005, through November 28, 2005. Common presenting clinical features included blurred vision (60%), anterior segment inflammation (49%), and cell deposition (56%). Of the patients, 100 (89%) had been exposed to a single brand of balanced salt solution manufactured by Cytosol Laboratories and distributed by Advanced Medical Optics as AMO Endosol. Two patients continued to have residual symptoms. There were no reports of significant breaches in sterile technique or instrument reprocessing. Of 14 balanced salt solution lots, 5 (35%) had levels exceeding the endotoxin limit (0.5 EU/mL). Based on these findings, the balanced salt solution product was withdrawn, resulting in a termination of the outbreak.

Conclusions: This is the first known report of an outbreak of TASS caused by intrinsic contamination of a product with endotoxin. Ophthalmologists and epidemiologists should be aware of TASS and its common causes. To facilitate investigations of adverse outcomes such as TASS, those performing cataract surgeries should document the type and lot numbers of products used intraoperatively.