FDAnews Device Daily Bulletin

FDA, BAUSCH & LOMB ANNOUNCE PERMANENT WORLDWIDE RECALL OF MOISTURELOC CONTACT LENS SOLUTION

May 16, 2006
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The FDA and Bausch & Lomb have announced that the company is permanently recalling its MoistureLoc contact lens solution.

Daniel Schultz, director for the FDA's Center for Devices and Radiological Health (CDRH), said that the root cause of a "spike" in infection rates of the Fusarium keratitis fungus in lens wearers has been traced to a "complex" interaction between the formulation of the MoistureLoc product and "certain use patterns." Schultz was unable to comment on what those use patterns are, but indicated that more information would become available in coming days.

Schultz also indicated that the South Carolina plant linked with a majority of the compromised products may be subject to a review for good manufacturing practices (GMP) violations. He stressed that an FDA review of GMPs at the plant is a separate matter from the issues related to the lens solution formula.