Updated from 5:24 p.m. EDT
Bausch & Lomb
stopped shipping its ReNu with MoistureLoc contact lens solution in the U.S. after an increased number of reports of fungal infections in contact lens wearers.
In a statement on its Web site, the Food and Drug Administration said the Centers for Disease Control has received reports of 109 cases of suspected fungal keratitis, a rare infection that may cause vision loss.
Of 30 patients for which complete data are available, 28 were contact wearers and 26 remembered which products they used. All of those 26 reported using the ReNu solution, and five reported using other products in addition to ReNu.
Bausch & Lomb said in a press release late Monday that available scientific evidence doesn't establish any type of ReNu solution as a cause of the infections.
"The CDC has not determined if these reports represent an increase of Fusarium keratitis infections and is continuing to investigate the association, if any, of these cases with any product," the company said in a press release. "Nonetheless, in the interest of public health, we will voluntarily suspend U.S. shipments of ReNu with MoistureLoc while we pursue all appropriate steps to bring this investigation to a definitive conclusion."
The company noted that none of its other products are affected by the move.
Shares of Bausch & Lomb tumbled $5.32, or 9.3%, to $52.12 in after-hours trading.
The company had already suspended sales of the ReNu solutions in Singapore and Hong Kong in February after multiple reports of fungal keratitis infections. Bausch & Lomb said in late March, though, that it believes that the root cause of the infections wasn't related to a specific contact lens or lens-care product. The company said many of the recorded cases in Asia involved poor patient compliance with lens care regimens.
The FDA said it is focusing on determining if certain behaviors, or specific products, increase the risk of infection.
ReNu with MoistureLoc, a multipurpose solution for soft contact lenses, was launched in late 2004.