The U.S. Food and Drug Administration (FDA) released a statement on Monday, May 15, 2006 announcing that Bausch & Lomb, makers of the ReNu MoistureLoc contact lens cleaning solution product that has been linked to at least 32 confirmed cases of Fusarium keratitis infection in the United States, has recalled the product worldwide.

ReNu MoistureLoc contact lens solution, manufactured in a Bausch & Lomb plant located in Greenville, SC, was voluntarily withdrawn from the U.S, market on April 13 after FDA and Centers for Disease Control (CDC) investigations determined that the majority of confirmed cases under investigation since March 22, 2006 appeared to have originated from that facility. The FDA and CDC investigations of the Greenville plant are still being finalized and a report has not yet been released; however Bausch & Lomb says the now decided to permanently remove the product worldwide.

The FDA reported that a team from Bausch & Lomb met with the agency on May 11 to share the results of their internal investigation into possible Fusarium keratitis contamination of their product. According to the FDA, Bausch & Lomb believes “unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection .” According to the CDC, the total number of confirmed U.S. cases of Fusarium keratitis has climbed to 122.

Bausch & Lomb faces several lawsuits as a result of injuries claimed to be a result of using the MoistureLoc product. A Florida woman says she lost her eye as a result of using MoistureLoc. At least eight other individuals say they underwent cornea transplants as a result of using MoistureLoc.

Approximately 2.3 million people use ReNu MoistureLoc, accounting for an estimated $100 million in global sales in 2005.

Sources: FDA Release, May 15, 2006, accessed May 16, 2006; Ben Dobbin, “Health Concerns Prompt Recall of Contact Cleaner,” Associated Press, May 16, 2006.