Bausch & Lomb has agreed to stop shipping its ReNu MoistureLoc brand contact lens solution in the United States after some users were diagnosed with serious eye infections. Bausch & Lomb had suspended sales of all ReNu solutions in Singapore and Hong Kong in February after reports of similar infections. The company later contended that tests found no evidence to suggest its products were the cause of the infections. The FDA says that 109 preliminary reports of a rare fungal infection that may cause loss of vision have been reported to the Centers for Disease Control and Prevention from 17 states in this country.
The FDA said it was not aware of a direct link between the Fusarium fungus and any specific product, but in 26 cases so far, patients used Bausch & Lomb’s ReNu MoistureLoc solution. Dr. Daniel Schultz, head of FDA’s Center for Devices and Radiological Health, told reporters:
We do not at this point have information that gives us a direct cause-and-effect link between any particular product or any particular action.
Bausch & Lomb Chairman and Chief Executive Officer Ronald Zarrella says the data is “troubling and perplexing, as there is an apparent disproportionate representation of U.S.-manufactured ReNu with MoistureLoc.” The halt in shipments was a further blow to Bausch & Lomb, which has delayed issuing its 2005 annual report as a result of internal accounting investigations. According to the FDA, the eye care product maker was not pulling any of its existing MoistureLoc product from U.S. stores, but urged the approximately 30 million Americans who wear soft contact lenses to keep their hands and lens cases clean. ReNu MoistureLoc generated U.S. sales of approximately $45 million in 2005 for the company.
U.S. health officials have complete information for 30 reported cases. Of those, 28 people wore soft contact lenses, and 26 of them reported using Bausch & Lomb’s ReNu brand in the month before the infection. Five patients reported using other solutions in addition to ReNu, including some made by Advanced Medical Optics Inc. and Alcon Inc. The fusarium infection may lead to vision loss requiring corneal transplants. The FDA has asked doctors to be vigilant when testing patients who contract any eye infection.
The FDA was not made aware of the CDC’s data on U.S. cases until March 8th. Both agencies are investigating the 109 reported cases, which occurred between June 15, 2005, and March 18, 2006. Tim Ulatowski, head of compliance for the FDA’s device center, said agency inspectors have already been to Bausch & Lomb’s manufacturing plants and warehouses testing various samples. At least two class action lawsuits have been filed against Bausch & Lomb. One is filed in New York and the other in Miami, Florida. I suspect there will be individual claims filed where the injury or disability is extensive. Of course, any injury to a person’s eyes is a serious matter and can be disabling.