Bausch & Lomb Permanently Halts Sales of Solution
Bausch & Lomb on Monday permanently terminated worldwide sales of its ReNu with MoistureLoc contact lens solution, which has been linked to the majority of recent eye infections caused by the Fusarium fungus, the Wall Street Journal reports.
CDC has confirmed 122 cases of the infection. Among the 98 cases that have been fully investigated, 63% were among patients who reported using the ReNu with MoistureLoc solution. An additional 20% said they used ReNu MultiPlus, and 10% said they used an unspecified ReNu brand (Pagan Westphal, Wall Street Journal, 5/16).
Ronald Zarella, chair and CEO of B&L, said the company last week concluded that MoistureLoc was formulated in a way that increases the risk of eye infection if consumers do not carefully follow the directions on the label, such as replacing and not reusing the solution in contact storage cases. The company said the MoistureLoc solution can leave a film on lenses that reduces the effectiveness of its sterilization agent (Feder, New York Times, 5/16).
FDA Center for Devices and Radiological Health Director Daniel Schultz said the outbreak of infections "appears to be related to the design of this particular solution and the way in which it is used." Schultz said FDA inspectors found violations of manufacturing practices at B&L's South Carolina manufacturing facility, but he added that the violations likely were not related to the infections.
Zarella said the company has fixed some of the problems identified by FDA (Rockoff, Baltimore Sun, 5/16).