AMO Complete MoisturePlus Recall During the week of May 21, 2007, U.S. health investigators linked Complete MoisturePlus, a contact lens solution made by Advanced Medical Optics Inc., to the outbreak of a rare but serious eye infection that can cause blindness. As of May 24, 2007, in a probe that includes 35 states and Puerto Rico, the U.S. Centers for Disease Control and Prevention (CDC) identified 138 culture-confirmed cases and has interviewed 46 patients. Research illustrates 36 of those people wore soft contact lenses, 21 reported using Advanced Medical Optics Complete MoisturePlus Multi-Purpose a month before symptoms, and 14 used it exclusively. That was enough of a link to a product with limited market share to spark a public announcement, said Sharon Roy, medical epidemiologist with the CDC’s division of parasitic diseases.
Eye infections from Acanthamoeba typically occur in contact lens wearers but are extremely rare, appearing on average in just one or two cases per million lens wearers per year. However, various eye-care centers around the U.S. have been tracking increased cases of the infection over the last three years. The CDC’s interest in the recent outbreak was prompted by research done in the Chicago area at the University of Illinois at Chicago, led by Charlotte Joslin and Elmer Tu. They have tracked 67 cases of the outbreak in the Chicago area since June 2003, and had a paper on the matter accepted Friday for future publication in the American Journal of Ophthalmology.
According to Ms. Joslin, who is familiar with the CDC’s plans and research, the agency was expected to announce details regarding the infections and connections to the Advanced Medical Optics solution on Friday. The findings are very similar to what the UIC study uncovered in the Chicago area -in 55% of 38 cases where researchers had complete data, the Advanced Medical Optics solution was at issue, Ms. Joslin said of the local study. The product in question posted U.S. sales of $12.6 million in the first quarter, compared with overall company sales of $251.7 million.
Earlier AMO Complete MoisturePlus Recall
On November 22, 2006, 2.9 million packets of its Complete MoisturePlus Multi-Purpose contact-lens solution and Active Packs have been recalled by Advanced Medical Optics Inc. after three lots sold in Japan were found to have bacterial contamination. The recall includes 183,000 Complete MoisturePlus units sold in the United States.
Advanced Medical Optics Inc., blamed the the contamination of the Complete MoisturePlus product on a water-borne organism that got into some solution at the company’s plant in China. The company has said that the plant has been shut down until the problem is corrected. Advanced Medical said that the lens solution itself is not responsible for the contamination. The Complete MositrePlus recall comes just six months after Bausch Lomb recalled its ReNU with MoistureLoc multipurpose solution after the product was linked with a Fusarium keratititis, a rare but serious fungal eye infection.
The contamination became apparent after a retailer in Japan complained that some bottles of lens cleaner appeared to be damaged. The company traced the units to the plant in China and found that Ralstonia bacteria had compromised the disinfectant in the solution and were eating away at the oxygen in the bottles.
Multi-purpose lens cleaners such as Complete MoisturePlus accounted for about 17 percent of Advanced Medical’s $920.7 million in global sales last year, according to the company’s annual report.