Contact Solution Recall Not Due to Manufacturing Problem

By: Daniel Yee AP
By: Daniel Yee AP

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," said James Mazzo, president and chief executive officer of Santa Ana, Calif.-based Advanced Medical Optics Inc., in a Tuesday morning conference call.

Government officials Friday warned people 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, 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. "All of our products ... have always met and continue to meet FDA requirements. Moisture Plus does what it is required to do."

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 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.

Chief Financial Officer Randy Meier said that the Moisture Plus products' $105.7 million in 2006 sales represent about 10 percent of the company's total consolidated sales.

"We're still working through the details to determine how much of that revenue will be impacted by the recall," Meier said. "It is impossible to assess what path we'll take or what the impact will be to our future earnings."

Meier said the company will update investors early next week.

"While this recall is clearly a setback for our eye care business, none of our other products will be affected," Meier said.

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

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

CDC officials said people should discard the solution, throw out their current contact lenses and toss away the lens storage case. All of them may harbor the infecting amoeba, said Michael Beach, team leader in the CDC's division of parasitic diseases.

An estimated 85 percent of U.S. cases of Acanthamoeba keratitis occur in contact lens users, but it's extremely rare. The estimated prevalence is one to two cases per 1 million contact lens wearers. Contact lens wearers who practice proper lens care and people who
don't wear contact lenses can still develop the infection.

(Copyright 2007 by The Associated Press. All Rights Reserved.)


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