Contact Solution Maker Failed To Report Problems

When questioned by FDA inspectors, company officials said they were not obligated to report the complaints because the product's labeling does not say it protects against Acanthamoeba, according to the FDA documents.

But consumer advocates criticize that reasoning.

"It's a little bit like saying, 'Our cars are not claimed to prevent crashes, and therefore we're under no obligation to make our cars as crash-proof as possible," said Dr. Peter Lurie of Public Citizen, a consumer advocacy group.

Kelly Morrison, a spokeswoman for Abbott Laboratories, which acquired AMO in February, said the company "believed it was reporting customer complaints in compliance with FDA regulations. She declined to elaborate. Abbott Laboratories is based in North Chicago.

The FDA documents illustrate just how much the government relies on manufacturers to report problems. They also raise questions about how aggressively regulators have gone after companies that don't report critical information.

Beginning in February 2006 and continuing through November, AMO received a series of complaints about users who were diagnosed with the Acanthamoeba infections. But those reports were not disclosed until June 2007, when FDA inspectors came to investigate the company's headquarters following its product recall.