Contact lens industry learning lessons of ReNu recall

Monday, 04 December 2006

Advanced Medical Optics Inc. has announced a recall for 3 million bottles of its Complete MoisturePlus contact lens solution. The company says that it found bacteria in three batches of solution made in its China factory. About 183,000 of the affected bottles had been sent to stores in the U.S. In addition to the recall, Advanced Medical says that it is working with officials in China and the Food and Drug Administration to tear down four manufacturing lines that produced MoisturePlus and to sterilize the entire plant where the contact lens solution was made. Advanced Medical seems to have learned a lesson from Bausch & Lomb, which faced a similar contamination of its ReNu with MoistureLoc line of contact lens solution earlier this year. Bausch & Lomb learned of an outbreak of the fungal eye infection Fusarium keratitis from Singapore officials in October 2005. However, the company hid the news of the infection link from officials at the FDA and only issued a worldwide ReNu recall in May 2006, months after US retailers had already started pulling ReNu with MoistureLoc from store shelves. Initially, Bausch & Lomb refused to acknowledge that ReNu with MoistureLoc was responsible for the infection outbreak, waiting until hundreds had suffered severe eye damage from Fusarium keratitis symptoms before issuing the ReNu recall. As a result, the FDA has been highly critical of Bausch & Lomb’s response to the Fusarium keratitis outbreak, citing the company for several health and safety violations in an October warning letter. Legal experts predict that Bausch & Lomb could be facing $1 billion in ReNu lawsuits because of its failure to warn U.S. customers and health officials of the infection outbreak among ReNu with MoistureLoc users. By contrast, Advanced Medical was quick not only to acknowledge the contamination of its MoisturePlus line but to pull the product from the market. The company has hired four consultants with expertise in drug regulations and product recalls to help it avoid the kind of slow response that hurt Bausch & Lomb during the ReNu recall.