It sounds like a reply of Bausch & Lomb's saga with its own ReNu with MoistureLoc solution. Advanced Medical Optics indicates that it is acting carefully with the steps it takes in recalling certain lots of its own 12-ounce Complete MoisturePlus multi-purpose contact lens solution. Bacterial contamination was found in three lots sold by AMO in Japan, and stemmed from a production issue at a plant in China. Products made at a factory in Spain, which supplies much of the range distributed to Europe and to the USA, have not been affected by the recall.
AMO is recalling 18 lots distributed in the USA that were manufactured at the same Chinese facility during the period in question. The remaining 2.9 million units being recalled by the company have been shipped to the Asia-Pacific region.
Not included in the recall are the 4-ounce and 16-ounce bottles of the solution, nor are professional samples or packs provided to eye care practitioners. About 183,000 units sold in the USA are being recalled, representing less than 1 percent of the Complete MoisturePLUS contact lens products that AMO distributes in the USA annually.
An investigation was launched after AMO's tests revealed contamination in three lots of solutions sold in Japan. The company said it immediately notified the proper global authorities, including the U.S. Federal Drug Administration (FDA). In the meantime AMO has ceased all production at the Chinese facility where the bacteria originated.
The recall should reduce the company's revenues for the remainder of 2006 and 2007 by $40-45 million. Because of this, AMO is now projecting 2006 revenues to total $985-1,000 million, as compared to previous guidance of $1,010-1,020 million. For 2007, AMO is now calling for revenues in the range of $1,060-1,080 million, compared with former budget of $1,080-1,100 million.