Temperature instability of ReNu With MoistureLoc: a new theory to explain the worldwide Fusarium keratitis epidemic of 2004-2006.

OBJECTIVE To investigate the effect of storage temperature on the ability of contact lens solutions to inhibit growth of Fusarium species. A 2006 Food and Drug Administration inspection of Bausch & Lomb's Greenville, South Carolina, manufacturing site indicated that Bausch & Lomb failed to regulate storage and transport temperatures of their products. METHODS Six contact lens solutions were studied: ReNu with MoistureLoc, ReNu MultiPlus, COMPLETE Moistureplus, AQuify, Clear Care, and OPTI-FREE RepleniSH. Two bottles of each solution were separately stored at room temperature and 60 degrees C for 4 weeks, serially diluted, and then tested for their ability to inhibit growth of 11 Fusarium isolates (7 of which were associated with the keratitis epidemic). RESULTS ReNu with MoistureLoc demonstrated the greatest decline in efficacy after 60 degrees C storage. Clear Care and ReNu MultiPlus performed the best. Regarding the keratitis epidemic isolates only, the ReNu with MoistureLoc bottle stored at room temperature allowed growth in 27 of 84 combinations vs 67 of 84 combinations with the 60 degrees C-stored bottle. CONCLUSIONS When exposed to prolonged temperature elevation, ReNu with MoistureLoc loses its in vitro fungistatic activity to a much greater extent than other products. Improper temperature control of ReNu with MoistureLoc may have contributed to the Fusarium keratitis epidemic of 2004-2006.