ReNu Recall

Bausch & Lomb initially learned of problems with its ReNu with MoistureLoc contact lens solution (used by 2.3 million people worldwide) in June 2005. From June to September, there was an increase of keratitis-related hospital admissions and Bausch & Lomb was informed. After initially downplaying the seriousness of the matter, Bausch & Lomb finally suspended sales of ReNu with MoistureLoc in Hong Kong, Singapore and Malaysia after the number of keratitis cases escalated. In early March 2006, a New Jersey ophthalmologist reported three cases of Fusarium keratitis to the Centers for Disease Control, at which time an investigation began. There were at least 30 cases within the U.S. by then—28 of which were contact lens wearers, and all but two of whom used ReNu products. By then, eight of the victims had undergone corneal transplants to prevent blindness. The FDA inspected Bausch & Lomb’s plant in Greenville, South Carolina, and there was enough evidence to convince Bausch & Lomb to take some steps, but it did not want to issue a full ReNu recall. On April 10, 2006, Bausch & Lomb stopped shipping ReNu with MoistureLoc to stores in the U.S. This was not a full ReNu recall, and the existing product could still be sold until supplies ran out. The number of cases of people suffering from Fusarium keratitis continued to grow in Singapore, although sales of the contact lens solution had been halted there two months earlier. After nearly three weeks of testing, the company insisted that neither it nor any of the five federal inspectors at its Greenville plant had been able to uncover evidence connecting the contact lens solution to the outbreak of Fusarium keratitis. The long, slow process of a complete ReNu recall continued in mid-April when Bausch & Lomb asked American retail stores to take ReNu with MoistureLoc off the shelves, at least temporarily. It did not, however, request that the contact lens solution be returned to the company, assuming it was in fact safe and would be for sale again soon. A similar contact lens solution (AMO Complete Moisture Plus Multi-Purpose) was recalled in May 2007.