A Medical Device Daily
In the wake of recent problems with the ReNu with MositureLoc contact lens cleaning solution - including a report by Reuters of the first of what promises to be many lawsuits - Bausch & Lomb (B&L; Rochester, New York) said it has asked U.S. retailers to remove the product from their shelves temporarily. And it recommended that consumers switch to another lens care solution for the time being until the investigation of reports of fungal keratitis infections among contact lens wearers in the U.S. is concluded.
The company said it was initiating the voluntary market withdrawal in order to eliminate any confusion among contact lens wearers about what to do while the investigation is ongoing, but it could be argued that it ultimately gave in to pressure from their larger customers.
Indeed, the decision to recall the product came just days after B&L Chairman and CEO Ronald Zarrella told analysts during a conference call that the company might be inclined to take back product if the situation was not resolved soon, apparently reversing its stated intent to simply halt shipment of new product and not reclaim those supplies already in stores (Medical Device Daily, April 13, 2006).
"Frankly, if it's not resolved in a reasonable amount of time, we'll take the product back," Zarrella said during that call.
The company probably already saw the writing on the wall and didn't want to squander what goodwill it had left as large drugs stores including Wal-Mart, Walgreens, CVS and Sears-owned Kmart had already pulled the product prior to the decision to institute a recall.
Early last week, the FDA and the Centers for Disease Control and Prevention (CDC) warned of an increase in reports of patients who wear soft contact lenses being infected with a fungus that may lead to blindness. B&L had already halted shipments of the product manufactured at its Greenville, South Carolina, facility.
The product suspension had followed release of a report by the CDC that it is reviewing reports of 109 cases in 17 states since June 2005 of suspected fungal keratitis, caused by the fusarium fungus.
The CDC said that the majority of cases have yet to be reviewed, but of the 30 cases reviewed so far, 28 involved contact lens wearers. Twenty-one people reported using ReNu contact lens care products; five reported using a combination of ReNu and products manufactured by Advanced Medical Optics (Santa Ana, California) and Alcon (Fort Worth, Texas).
Concern about an increased incidence of the fungal infection among users of B&L products first arose in Singapore, where health officials noticed an increase in reports of infection in January and discovered 39 cases involving contact lens users from 2005 to February of this year. Cases have also been reported in Malaysia and Hong Kong.
The company placed ads in USA Today and regional newspapers on Friday and Sunday featuring an open letter to consumers from Zarrella explaining the situation and providing guidance on alternatives.
"For more than 150 years, Bausch & Lomb's mission has been to enhance your vision," said Zarrella in his letter. "We find ourselves in a position where the safety of one of our products, ReNu with MoistureLoc manufactured at our United States plant, is in question. We've done a series of exhaustive tests on the product, and a thorough inspection of the plant, and nothing has yet been found to show that ReNu with MoistureLoc contributed to these infections in any way. However, in the cases of infections reviewed to date, the majority of patients reported using ReNu with MoistureLoc manufactured at our U.S. factory."
The company, which said the action does not apply to other B&L products or to ReNu with MoistureLoc manufactured at factories outside the U.S., said it continues to collaborate with the FDA, the CDC, major eye centers and health authorities in a comprehensive investigation to identify the cause of the reported infections.
"Bausch & Lomb's first priority is the health and safety of consumers," said Zarrella in the letter. "If there is a problem with our product, we'll find it and we'll fix it. If there's not, when we come back you'll be able to know with absolute certainty that we've taken every possible step to ensure your safety."
The company said it continues to encourage contact lens wearers to strictly follow the contact lens wear and care recommendations of their eye care professionals in order to be sure they continue to enjoy safe and comfortable contact lens wear.
In another recall action, the German Federal Institute for Risk Assessment (BfR) issued an update on efforts to understand why a product called Magic Nano - a household glass and ceramic tile sealant in an aerosol can - may have caused respiratory problems when used in confined spaces.
This is believed to be the first health-related recall of a nanotechnology consumer product.
The product was first sold in supermarkets and discount stores in late March. It was recalled by the manufacturer, Kleinmann , a German subsidiary of Illinois Tool Works (Glenview, Illinois) after BfR issued a product warning on March 31.
Between March 27 and March 30, 97 people who reportedly used the aerosol spray claimed to suffer from health problems ranging from trouble breathing to six cases requiring hospital treatment in which water accumulated in the lungs.
Despite meetings between BfR and the manufacturer, clear information on what is in the product and how it was tested for safety is still lacking.
According to BfR, it is possible that the reported adverse effects were associated with very fine airborne droplets produced by the aerosol.