What's more, company officials and the Centers for Disease Control and Prevention (CDC) in Atlanta still have no idea what caused the outbreak of Acanthamoeba involving 138 users of AMO's Complete MoisturePlus lens solution. The parasite is far more common than that which caused the Fusarium fungal infections linked to a Bausch and Lomb product last year, and rarely infects the eye. But Acanthamoeba packs a powerful punch when it does, and is difficult to treat.
The impact is quite serious. Dr. Robert Cykiert, a leading ophthalmologist at the New York University Medical Center and a clinical associate professor at the NYU School of Medicine, was quoted in the New York Times this morning as saying that up to half of those acquiring the Acanthamoeba infection will require corneal transplants, vs. 30 per cent of those suffering a Fusarium fungal infection.While the cause may still be a mystery, the manufacturer and the CDC in Atlanta are advising users of AMO Complete MoisturePlus to dispose of any unused bottles of the product, the lens cases and even the lenses themselves.
It is projected that close to two million Americans could be at risk, based on Advanced Medical Optic's market share of the thirty million wearers of contact lenses in the U.S.
The History
On Friday of last week, Advanced Medical Optics announced a voluntary recall of its Complete MoisturePlus Lens solution after the CDC in Atlanta linked 138 cases of Acanthamoeba infection to the product. The recall came the same day as the CDC advised the company about is' preliminary study of Acanthamoeba victims since early 2005 showed that users of AMO Complete MoisturePlus were found to be seven times more likely to suffer an infection.
Ironically, the day before the recall, Advanced Medical announced its' interest in pursuing the purchase of eye care products maker Bausch and Lomb, the company that was hit with the Fusarium fungal recall last year over its' ReNu with MoistureLoc solution. The takeover bid for control of B&L, a much larger company than Advanced Medical, is on hold for now while AMO focuses on managing the recall, and determining the origins of the outbreak.
They've been down this road before
To the manufacturer's credit, Advanced Medical reacted swiftly once it was advised of the CDC's findings - unlike rival Basuch and Lomb, which was accused of dragging its heels for weeks over the ReNu Fusarium Keratitis infections of 2006.
Still, there have been problems in the past for AMO. In November, Advanced Medical recalled 2.9 million packets of its Complete MoisturePlus and Active Packs after three lots in Japan were found to have bacterial contamination. Of those, 183,000 units were sold in the United States. At the time, the company blamed the contamination on a water-borne organism that somehow managed to creep into the solution at the AMO plant in...wait for it.... China (Menu Foods, tainted tooth paste). That sterility issue has since been resolved, the company says, but there remains a question mark for anyone with concerns about where the products introduced into one of the most vulnerable areas of the body, are made.
While it has not been disclosed just where the AMO Complete MoisturePlus solution was made, it has been reported that Advanced Medical's manufacturing facility located in Alcobendas, Spain is the primary supplier for the U.S. and European markets.
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Doctors have begun fielding what is expected to be a flood of calls from concerned users.
The sleuthing into the cause of the outbreak - and the Centers for Disease Control and Prevention DOES use the 'O-word' - continues. Meantime, Advanced Medical Optics reported year-end sales of U.S. $997.5 million for 2006, and adjusted projections for 2007 - following the 2006 recall - were for revenue in the range of $1.06 to $1.08 billion dollars. The company will no doubt have to revise those projections downward.
The last major outbreak of Acanthamoeba was in the early 1980's.