AMO Complete MoisturePlus Recall: Many Missed the Memo…

Santa Ana, CAThe problem with a product recall is that it's only as effective as the communication between the manufacturer, and the end user. In the case of James Millard Wilson, he didn't get the message. The young art student from Baltimore had been having trouble with his eyes, and had no idea that his AMO Complete MoisturePlus Contact Lens solution had been recalled.

That voluntary recall happened in May of last year, after an investigation by the Centers for Disease Control and Prevention (CDC) in Atlanta linked the AMO product to a rare, but serious eye infection known as Acanthamoeba keratitis (AK). That recall was reclassified to a Class 1 recall in late July of that year, tagging the AMO Complete MoisturePlus as having a reasonable probability that serious adverse health consequences, or death was possible, according to the Class 1 parameters. It has been reported that the US Food and Drug Administration (FDA) had alerted health care professionals, and users of soft contact lenses about the recall. However, lawsuits have claimed that Advanced Medical Optics (AMO), based in Santa Ana, California failed in its responsibility to adequately notify consumers and retailers about the problem.

Wilson was one of those people who fell through the cracks and consumer advocates say that there are many like him, which is the reason why—as swift as AMO was in getting the word out back in May of 2007 when the link to AK was first established—manufacturers need to do a more thorough job of communicating a recall if people like Wilson are to be reached.

Especially when one considers the size of the recall—28 million bottles of AMO Complete MoisturePlus.

Wilson told National Public Radio (NPR) that he began wearing soft contacts in April of 2007, and used a bottle of AMO Complete MoisturePlus acquired from his eye doctor. By the end of June he began noticing that his eyes were becoming irritated, but he blamed the problem on his summer job as a house painter. It would be easy to assume that the dust from scrapings, and even the paint fumes may have had a role to play.

"It was a very sharp, stinging pain," he told NPR. "Often I wasn't able to open my left eye." He made it to work the next day in spite of the pain. A co-worker took one look at his irritated eyes, and convinced him to get to the hospital.

The diagnosis was AK, and as a user of AMO Complete MoisturePlus and thus a member of the high-risk group associated with the outbreak of Acanthamoeba keratitis, it was assumed that his condition had been caused by his usage of the product. As AK is actually caused by an amoeba that is naturally found in the environment, including some water sources, it is felt by the CDC that the AMO Complete MoisturePlus certainly would not have caused Acanthamoeba keratitis, but more correctly allowed the infection to occur.

In Wilson's case, he fell through the cracks partly due to his lifestyle. He had been living in a loft apartment without an Internet connection. Television reception where he lived was lousy, and he chose to read an alternative newspaper, rather then mainstream media. The former contained no notice, or notification about the recall. He had no idea the product had been recalled, and it was later determined that he wasn't alone. Others had 'missed the memo,' as bottles of the recalled product were still to be found on some store shelves. The FDA had to send out a second release at the end of July, together with a reclassification of the recall, in an effort to reach more users.

Wilson gave up on his contact lenses and is wearing glasses now, but endured a great deal of pain and discomfort to get to that point. Others haven't been quite so lucky, and have launched lawsuits alleging that while initial response on the part of the manufacturer was laudable, ongoing efforts were insufficient given the size and the breadth of the recall.

When it is the eyes you are dealing with, you don't want to take any chances—lest you finally get the memo, but your eyes are so bad you can't even read it…