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Federal, state, and local health officials are investigating at least 109 cases of Fusarium keratitis in which the use of a contact lens solution may have played a role.
Bausch & Lomb, which had stopped shipment of the product, ReNu with MoistureLoc, asked retailers in mid-April to pull all of the product off shelves. This is a precautionary action "to eliminate any confusion among contact lens wearers about what to do while the investigation is ongoing," according to a company statement.
Meanwhile, the Food and Drug Administration is inspecting a Greenville, S.C., manufacturing facility that is thought to be the source of most of the solution.
Seventeen states have reported cases to the Centers for Disease Control and Prevention. Of the first 30 cases that were fully investigated, 28 were associated with soft contact lens use; 2 reported no contact lens use, said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in a press briefing sponsored by the agency.
Of the 26 patients who remembered which solution they used in the month before the infection, all had used the Bausch & Lomb ReNu brand or a generic solution made by the company; 5 patients used additional solutions from Advanced Medical Optics Inc. and Alcon, among others.
Eight patients have required corneal transplantation.
It is not clear what is causing the infections. Overnight use of lenses is known to increase the risk of fungal infection, but only 9 of the 26 patients reported such use.
Source: HighBeam Research, Fusarium-linked contact lens solution pulled.(Clinical Rounds)