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B&L suspends shipping of contact lens solution after reports of fungal infections
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Bausch & Lomb announced April 10 that it has agreed to temporarily suspend U.S. shipments of ReNu with MoistureLoc as the Food and Drug Administration and Centers for Disease Control and Prevention investigate the increasing number of fungal keratitis cases in soft contact lens wearers reported in 17 states.
Although the link between lens care solution and the infection is not definitive, several patients have reported using various ReNu products from multiple product lots in the month prior to the onset of infection. The FDA is advising soft contact lens users to use ReNu MoistureLoc with caution and to report any signs or symptoms of infection to their physician immediately.
Bausch & Lomb reported that ReNu with MoistureLoc solutions generated approximately $45 million in U.S. sales in 2005.
In a Morbidity and Mortality Weekly Report (MMWR) Dispatch Monday, the CDC reported that it has received reports of 109 U.S. cases of suspected Fusarium keratitis, a rare but serious fungal infection that is usually associated with trauma to the surface of the eye, typically with plant material.
“An ongoing investigation by CDC, state and local health departments, and the Food and Drug Administration is under way to determine whether this cluster represents an increase of Fusarium keratitis infections and to determine the association, if any, of these cases with any product,” the MMWR stated.
In the meantime, the FDA recommends that eye care professionals should consider a fungal infection and obtain a specimen for lab analysis if a patient presents with microbial keratitis. Patients should also be referred to an ophthalmologist for immediate treatment.
All cases of fungal keratitis in contact lens wearers should be reported to the FDA.
FDA will be sharing reported information with CDC. Practitioners can report directly to MedWatch, the FDA’s voluntary reporting program, by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online www.fda.gov/medwatch/report.htm.