It is believed that Bausch & Lomb knew or should have known of the dangerous risks of the product on or before May 15, 2006, when it withdrew the product from the worldwide market. It is clear that Bausch & Lomb knew at the latest in November 2005 of outbreaks of Fusarium Keratitis among the product's users in Singapore, Malaysia, and Hong Kong. Yet it appears taht Bausch & Lomb continued to distribute the product outside of Asia and specifically in the United States. Finally, around April 10, 2006, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) issued a press release "alerting health care professionals and their patients who wear soft contact lenses to an increasing number of reports in the United States of rare but serious fungal infections in the eye that can cause permanent loss of sight." The press release continued, "Some patients have reported a significant loss of vision, resulting in the need for a corneal transplant. A fungus called Fusarium has been identified as the cause of the reported infections."
Only then did Bausch & Lomb announce that it was suspending shipments of the product due to reports of Fungal Keratitis infections among users of the product. Around April 13, 2006, Bausch & Lomb issued a press release stating that "Bausch & Lomb today asked U.S. retailers to remove ReNu with MoistureLoc from their shelves temporarily, and recommended that consumers switch to another lens care solution for the time being, until the investigation of reports of fungal keratitis among contact lens wearers in the United States is concluded."
On or about May 19, 2006, the Center for Disease Control affirmed that the only contact lens solution with a significant association with Fusarium keratitis infection was the Bausch and Lomb product ReNu with MoistureLoc. The Center for Disease Control has reported that a majority of the confirmed Fusarium cases in the United States during the most recent reporting period have been associated with the ReNu with MoistureLoc. The number of cases of Fusarium keratitis associated with ReNu with Moisture Loc is disproportionate compared to the overall product market share. The number of cases associated with other contact lens solutions have not been disproportionate with market share and are comparable to background rates of infection in the general population.
