Bausch & Lomb recalls, discontinues contact lens solutionMay 16, 2006 | Baltimore Sun
Bausch & Lomb Inc. said Monday it would no longer make its ReNu with MoistureLoc contact-lens solution and was recalling the product worldwide after linking certain uses to a potentially blinding eye infection.
The company decided to remove the solution from store shelves after 122 patients in 26 states developed the rare infections caused by a commonly occurring fungus that inflames the cornea.
After months of investigation in cooperation with federal health officials and regulators, Bausch & Lomb concluded that infections from the solution developed in combination with certain customer habits, such as leaving the bottle open, letting the solution evaporate in the lens case or allowing the lens case to dry without washing it first.
"We believe that these infections may involve a perfect storm of factors," said Ronald Zarrella, chairman and CEO of the Rochester, N.Y.-based company in a conference call with Wall Street analysts.
Federal health officials first learned of the problem March 8, when a New Jersey ophthalmologist reported three cases to the Centers for Disease Control and Prevention in Atlanta. Retailers stopped selling the solution.
Last month, the company stopped shipping batches made at its Greenville, S.C., plant and then asked retailers to remove any on their shelves.
Bausch & Lomb took the latest and most drastic step after determining the product's formula was partly responsible for the spike in infections, which have also been reported in Hong Kong and Singapore.
After polymers in the solution are exposed to air, a film develops and the fungus prevalent in bathroom sinks can adhere to it, Zarrella said.
The outbreak "appears to be related to the design of this particular solution and the way in which it is used," said Dr. Daniel Schultz, director of the Food and Drug Administration's device center.
Schultz said FDA inspectors found some problems at the Bausch & Lomb plant in Greenville that manufactured the contact lens solution but did not believe they played a role in the higher incidence of eye infections among users.
Zarrella said Bausch & Lomb has already fixed many of the problems identified by inspectors.
Introduced in late 2004, ReNu with MoistureLoc was used by 2.3 million Americans and 5 million consumers worldwide and had $100 million in sales last year.
Zarrella estimated the recall will cost $50 million to $70 million.
The company urged contact lens wearers to wash their hands, change their lenses and lens cases, clean out the cases and always use new solution each time they clean their lenses.