The recalled contact-lens solution ReNu with MoistureLoc had maintained a 2 percent market share into the early weeks of September, despite the fact that distribution of the Bausch and Lomb product was halted by the company on April 9. Use of that solution has been connected to a serious fungal condition known as Fusarium keratitis, but recent market data call into question whether or not the company has been aggressive and diligent enough in alerting retailers, patients, and medical professionals to the product’s potential dangers.

In their announcement of Bausch and Lomb’s decision in April, the FDA said that the company was “voluntarily stopping shipment of the ReNu MoistureLoc product while they are continuing to investigate the cause of these infections. Soft contact lens users who have existing supplies of the Renu Moisture Loc should use the product with caution and report any signs and symptoms of eye infection to their doctors.” The following week, the company issued what they called a “voluntary market withdrawal,” which requested that retailers temporarily suspend sales while research was ongoing.

It wasn’t until the following month that Bausch and Lomb announced a permanent withdrawal of the product from shelves, in the face of mounting evidence that the product carried the significant risk of Fusarium keratitis, which can cause permanent damage including blindness. This permanent recall came only after the Centers for Disease Control had confirmed more than 100 cases of the condition around the country. In more than two thirds of those cases involving contact-lens users, the sufferer had used ReNu with MoistureLoc.

Bausch and Lomb has encountered a great deal of criticism for their handling of the situation. Many researchers allege that the company had reason for concern about the product’s safety well before they announced any action in April. Many critics believe that the company had been alerted by medical officials in Hong Kong about the potentially dangerous side effects as far back as November of 2005.

In addition, the company has failed to do enough to inform users and doctors of the risks involved. Observers have found that the product can still be found on the shelves of some retail outlets, perhaps indicating that Bausch and Lomb hasn’t adequately reached out to its retailers to inform them of the recall.

This entry was posted on Tuesday, October 24th, 2006 at 3:48 pm and is filed under Legal News.