Santa Ana, CA-Advanced Medical Optics Inc. (AMO) is voluntarily recalling 18 lots of its Complete MoisturePLUS multipurpose contact lens care solution distributed in the United States after water-borne bacteria were discovered in a small number of bottles, the company said.
The recall is part of a larger effort involving 2.9 million bottles made in China and distributed in the United States, Japan, and the Asia-Pacific region, and another 5 million bottles still under AMO control, according to the company.
AMO launched an investigation in September after a Japanese retailer discovered a dented bottle in a newly opened carton of solution and alerted the manufacturer, said Sheree Aronson, AMO's vice president of corporate communications and investor relations, in an interview with Ophthalmology Times.
Tests indicate just 0.03% of the 2.9 million units on the market could be compromised, she added.
"But nevertheless, that could pose a health risk to patients, so we thought it made the most sense to just get it off the market," she said.
Investigators detected the presence of Ralstonia, a common water-borne bacterium, in the defective bottles. Because disinfecting agents were attacking the bacteria, which Aronson said are not a known ocular pathogen, the disinfectant potentially would be incapable of fighting irritation-causing pathogens.
The company has fielded questions from many consumers, but no adverse reactions have been definitively linked to use of the product.
Although defective products originated in two of the four production lines, AMO has shut down its plant in China to clean and sanitize it. It also has moved up planned production line improvements. The plant will be closed a total of 10 to 12 weeks, she said.
"What that means is, there's a period when we will not be able to meet the demand for supply in the Asia-Pacific market," Aronson explained.
The majority of MoisturePLUS solution sold in the United States and Europe is produced at a plant in Spain, which is operating at capacity and was not affected by this contamination. The plant in China began boosting the supply to the United States in late 2004, Aronson said.
The plant in China also produces hydrogen peroxide solutions as well as private-label products for Japan and China. None of these products, however, is affected by the recall, she said.
MoisturePLUS solution was launched in 2003.
In addition to the MoisturePLUS solution, AMO also is recalling "a number of lots" of its Blink-N-Clean rewetter and its Lens Plus Ocupure saline solution, Aronson said. These products were distributed only in its Asia-Pacific region, which does not include Japan, she said.
In all, 116 lots were recalled in the Asia-Pacific region, 17 in Japan, and 18 in the United States. The U.S. lots account for less than 1% of Complete MoisturePLUS contact lens products distributed in the United States each year, the company said.
The company expects the recall to reduce revenue for the rest of 2006 and 2007 by $40 million to $45 million, due to product returns, supply shortages, and lost market share in Japan and the Asia-Pacific region.
AMO also expects costs of about $35 million to $40 million due to inventory write-downs, recall costs, plant costs, freight and logistics costs, and additional marketing expenses.
Aronson insisted that the production-line problems they experienced are vastly different from the problems encountered earlier this year by Bausch & Lomb when the formulation of its ReNu with MoistureLoc contact lens cleaning solution was linked to an outbreak of fungal keratitis. The solution ultimately was pulled from the market in May (See the May 15, June 1, June 15, July 1, and Sept. 15, 2006, issues of Ophthalmology Times).