Atlanta – The company involved in a voluntary recall of a contact lens solution said Tuesday it stands by its product and blamed improper handling of contact lenses for the eye infections that forced the product to be pulled from the shelves.
“What we’re trying to handle right now … is what the CDC hit us with,” James Mazzo, president and chief executive of Santa Ana, Calif.-based Advanced Medical Optics Inc., said Tuesday.
Government officials Friday warned people to throw away AMO Complete Moisture Plus Multi-Purpose Solution, used 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, a painful eye infection caused by a waterborne organism that, untreated, can lead to permanent vision loss or blindness, the Centers for Disease Control and Prevention said.
“It’s not a manufacturing problem or a contamination issue,” said Mazzo, who added that the infection, also called 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.
CDC officials said they drew a link between the Advanced Medical Optics product and the infection because 58 percent of confirmed cases who wore soft contact lenses had used the solution in the month before onset of symptoms, and 39 percent had used only that solution.
They calculated that wearers of soft contact lenses who had the infection were at least seven times as likely to have used AMO Complete Moisture Plus as 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.
Chief financial officer Randy Meier said the Moisture Plus products’ $105.7 million in 2006 sales represent about 10 percent of the company’s total consolidated sales.
