Company blames contact lens users, not solution, for infections

The company involved in a voluntary recall of a contact lens solution said Tuesday it stands by its product and blamed lens users for the eye infections that forced the product off the shelves.

'It's not a manufacturing problem or a contamination issue.' CEO James Mazzo

"What we're trying to handle right now is what the CDC [Centers for Disease Control]hit us with," James Mazzo, president and CEO of Santa Ana, Calif.-based Advanced Medical Optics Inc., told a conference call.

Health officials warnedconsumers in Canada and the U.S.on Friday to throw away AMO Complete Moisture Plus Multi-Purpose Solution, using for cleaning and storing soft contact lenses, after an investigation linked it to a rare eye infection.

The solution seems to be a factor in cases of Acanthamoeba keratitis, or AK, a painful eye infection caused by a waterborne organism that, untreated, can lead to permanent vision loss or blindness, said the U.S. Centers for Disease Control and Prevention.

"It's not a manufacturing problem or a contamination issue," said Mazzo, adding that AK affects people who improperly handle contact lenses, such as disinfecting them with water or wearing them while swimming or showering.

"AK is something the vast majority of contact lens users typically avoid by following their eye practitioner's advice," Mazzo said. "All of our products have always met and continue to meet FDA requirements. Moisture Plus does what it is required to do."

CDC investigation continues

CDC officials said they drew a link between the Advanced Medical Optics product and the infection because 58 per cent of confirmed cases who wore soft contact lenses had used the solution in the month before onset of symptoms and 39 per cent had used only that solution.

They calculated that wearers of soft contact lenses who had the infection were at least seven times more likely to have used AMO Complete Moisture Plus than healthy people who wear soft contact lenses.

It's generally difficult to draw a strong statistical conclusion from a small number of cases, but in this case an association between the product and the infection was clear-cut, CDC officials said.

Health officials will continue to investigate why the association exists. But in the interest of public health, they decided a warning was necessary, said Dr. Sharon Roy, the CDC epidemiologist who led the investigation.

The CDC and the U.S. Food and Drug Administration are investigating 138 confirmed cases of AK since January 2005.

AMO to update investors

Chief financial officer Randy Meier said that the $105.7 million US in 2006 sales of Moisture Plus products represent about 10 per cent of the company's total consolidated sales.

Meier said the company will update investors early next week.

Shares of Advanced Medical Optics fell 12 per cent to $34.34 in morning trading Tuesday.