WASHINGTON — Complaints about a contact lens solution linked to a 2007 outbreak of eye infections that blinded several people went unreported by the manufacturer for more than a year, government documents show.
The documents show Advanced Medical Optics received complaints about the solution more than a year before it was recalled and failed to promptly report nine complaints as required by law.
The company pulled its Complete MoisturePlus off the market in May 2007 after the Centers for Disease Control and Prevention linked the fluid to dozens of cases of a serious infection called Acanthamoeba keratitis.
Lawyers for customers suing AMO obtained the documents, which stem from a previously undisclosed inspection by the Food and Drug Administration, through a Freedom of Information Act request. The papers were obtained by The Associated Press.
It is impossible to know whether the reports would have triggered an earlier recall had they been submitted to the FDA. But medical experts say they certainly should have sounded an alarm.
Of roughly 70 plaintiffs suing AMO and represented by the law firm Schmidt LLP, three had eyes removed, three others suffered blindness and about two dozen had at least one corneal transplant.
The others suffered permanent vision damage.
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.
