Contact Solution Maker Failed To Report Problems

Acanthamoeba infections generally occur in one to two contact lens wearers per million. With 30 million contact lens wearers in the U.S., the expected national rate of infections would be 30 and 60. Yet that figure exploded to more than 100 in 2007.

The recall of AMO's solution was one of two high-profile product recalls in the middle of the decade in products linked to eye infections. The other a Bausch & Lomb product tied to an eye fungus.

Product recalls are expensive, as AMO had already learned the hard way. In November 2006, it slashed sales estimates by more than $40 million after voluntarily recalling 18 batches of contact solution at risk of bacterial contamination. The issue was unrelated to Acanthamoeba. AMO would lose tens of millions more in sales after the May recall, before ultimately being bought out by Abbott.

Hauling companies into court for reporting violations takes significant money and manpower — two things consumer advocates say the FDA has long lacked. But Public Citizen's Dr. Sidney Wolfe argues that not disciplining companies endangers the public health by encouraging reckless corporate behavior.

"Enforcing the criminal statutes is so important because these inspection reports are a matter of public record," said Wolfe, who is the group's acting president. "If other companies notice that violations don't lead to any criminal investigation, that's a big problem."