Bausch & Lomb has ordered a permanent worldwide retraction of its ReNu with MoistureLoc solution, which continues to be under investigation by the U.S. Federal Drug Administration on suspicion that it has been connected with a recent outbreak of an eye disease, Fusarium keratitis. The solution generated about $100 million in revenues for the company last year.
While the number of reported cases of Fusarium keratitis infection has grown to 130 in the USA, some of the affected consumers have for the first time said they used contact lens solutions from companies other than B&L. The U.S. Centers for Disease Control (CDC) said three of the victims used a product from Advanced Medical Optics and three others used an Alcon product.
AMO had gone out of its way last month to distance itself from the epidemic, issuing a formal statement to Vision Monday purporting that its Complete solution was safe, with no direct connection with the infection, after an exhaustive review. Alcon echoed this, adding that it was contacting the CDC about the matter.
At first, B&L had only recalled the solution in Singapore. It then took action in the USA, suspecting that any connections between the solution and the outbreak had stemmed from a production plant in South Carolina which serves the USA and only certain Asian markets. Five outbreaks of the infection have recently been reported in Europe, but B&L said this small number does not represent an unusual trend as the infection is known to occur in the continent, albeit infrequently.
Ron Zarella, the company's chief executive, maintains that there still is no evidence of tampering, counterfeiting, sterility failure or product contamination related to the solution after thousands of tests have been performed and millions of dollars have been spent to try to solve this problem. He said the conclusion thus far is that the MoistureLoc solution may be increasing the risk of infection in unusual circumstances. B&L has launched a 30-second television commercial in the USA in which Zarella explains that the company is recalling the ReNu with MoistureLoc product, while telling consumers about the company's strong and proud history and reassuring them that the company's other contact lens cleaning products are safe.
In a different breath, Bausch & Lomb chastised the media for ?erroneously? suggesting that it had withheld from the U.S. Federal Drug Administration information about early reports of the infection in Singapore. An official statement from the FDA said that B&L had ?failed to notify the agency of 35 serious injury reports of Fusarium keratitis from Singapore's minister of health in February 2006,? and said that none of the complaints had been reported to the agency before April 7. B&L has countered this by saying that it had made contact with the FDA's Office of Compliance in the Center for Devices and Radiological Health within days of the initial reports. The company said it continued to keep the agency updated as information became available. Ensuing lawsuits from victims of the infection have added salt to the company's wounds.
Separately, B&L said that it will file its 2005 financial report soon, as investigations into underhanded accounting practices at a Brazilian subsidiary have been completed, and a separate investigation at a Korean subsidiary is nearly finished.