Advanced Medical Says Contact Lens Solution Recall Not Due To Manufacturing Problem

Tuesday, May 29th 2007, 8:33 am

By: News On 6

ATLANTA (AP) _ The company involved in a voluntary recall of a contact lens solution said Tuesday there was no manufacturing problem or contamination issue involved in its decision to pull the product 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 that 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.''

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.

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

Mazzo said the CDC interviewed 46 people who were confirmed to have the infection dating back to 2005, 39 of whom were soft contact lens users. Of those users, 21 reported using the AMO solution.

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.

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