Renu MultiPlus

Renu MultiPlus

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

Due to an alarming number of adverse event reports received by the FDA and the Centers for Disease Control (CDC), the FDA investigated a Bausch & Lomb facility in Greenville, SC, linked to cases of a fungal eye infection known as Fusarium keratitis, a rare bacterial infection, in the U.S., Singapore and Hong Kong. In its preliminary statement on its investigation, the FDA found 20 potential violations in the Greenville, SC, facility. Among the most serious findings in the report was the fact Bausch & Lomb did not report to the FDA or the CDC that 35 cases of Fusarium keratitis in Singapore were confirmed as being linked to their product within 35 days as required for products manufactured in the United States. The company had reports of problems as early as July 2005 but had not reported details to the FDA as of May 9, 2006.

The eye infection reported in these cases, a rare but extremely serious microbial keratitis caused by the fungus Fusarium, may cause personal injury and vision loss severe enough to require corneal transplants in affected individuals. Fusarium keratitis requires up to three months of treatment and may cause corneal scarring and permanent blindness.

As of April 27, over 200 cases of fungal keratitis have been reported to these federal agencies, with 73 of them traced to a product manufactured by Bausch & Lomb: ReNu with Moisture Loc, a contact lens cleaning solution. As of May 15, 2006 122 cases of Fusarium keratitis have been confirmed in the U.S., and healthcare researchers, including doctors at the Centers for Disease Control and Prevention, determined in August that ReNu with MoistureLoc cleaning solution is the only contact lens product known to have contributed to eye infections in contact lens wearers. Instances of personal injury related to fungal keratitis have been reported in 33 different states, and over one-third of the 164 contact lens wearers with confirmed cases of fungal keratitis required corneal transplantation to recover their eyesight.