In what it is calling a "voluntary market withdrawal," Bausch & Lomb is asking retailers to stop selling ReNu with MoistureLoc, a contact-lens solution that's suspected of causing a serious eye infection. Many major retailers have already pulled the product and the company has suspended shipments.
The action is not a recall. The company is not asking stores to return the product, but rather to take it off the shelves while the investigation into the outbreak of fungal infections is concluded.
The Centers for Disease Control and Prevention (CDC) says it has received new reports of the fungal infections that have been linked to the solution, which is used for storing, cleaning and wetting soft lenses. But the agency refused to say how many additional complaints it had received.
Earlier this week, CDC and the Food and Drug Administration said they had information on 109 suspected cases of Fusarium keratitis, an infection that can lead to blindness. Of the 109 cases, 30 had been reviewed and 26 of those involved patients who had used ReNu.
Major retailers were quick to pull the product after learning of the problem. Kmart, Sears, Wal-Mart, Walgreen, CVS, Rite Aid and Drugstore.com all said they had stopped selling the product.
Consumers who return their ReNu to the company will have the choice of getting their money back or receiving a coupon for other Bausch products. Information is at www.bausch.com or call 1-888-666-2258.
The company is placing ads in major newspapers today featuring an open letter to consumers from Bausch & Lomb Chairman and CEO Ron Zarrella explaining the situation and providing guidance on alternatives.
"Bausch & Lomb's first priority is the health and safety of consumers," said Zarrella in his letter. "If there is a problem with our product, well find it and well fix it. If theres not, when we come back youll be able to know with absolute certainty that weve taken every possible step to ensure your safety."
In "exhaustive tests on the product" and an inspection of its manufacturing plant, "nothing has yet been found to show that ReNu with MoistureLoc contributed to these infections in any way," Zarrella's letter said. "However, in the cases of infections reviewed to date, the majority of patients reported using ReNu with MoistureLoc manufactured at our U.S. factory," which is in Greenville, S.C.
An FDA inspection of the Greenville plant in 2002 turned up some quality-control issues that the agency detailed in a warning letter to the company. The FDA found that the company "failed to establish and maintain procedures to adequately control environmental conditions, or other sources of contamination, which could reasonably be expected to have an adverse effect on product quality."