FDA faults Bausch & Lomb for delay in reporting ReNu infections

Monday, 06 November 2006

The Food and Drug Administration has criticized Bausch & Lomb for failing to report almost three dozen eye-infection cases that were linked to its ReNu with MoistureLoc contact lens solution. According to the FDA’s 11-page warning letter, Bausch & Lomb had been alerted regarding 35 cases of the fungal eye infection Fusarium keratitis in Fall 2005 by officials in Singapore. Because of the higher number of cases of Fusarium keratitis symptoms among ReNu with MoistureLoc users, officials there suspected a link between the two. Although Bausch & Lomb issued a ReNu recall in Singapore in February 2006, it did not notify the FDA of the infection cases within the allotted time period. Federal officials only became aware of the possible infection link when they were tipped off by Dr. David Chu, an eye doctor in New Jersey. After the Centers for Disease Control and Prevention noted more than 100 cases of Fusarium keratitis symptoms among ReNu with MoistureLoc users, Bausch & Lomb was forced to issue a worldwide ReNu recall in May. The FDA’s letter criticized Bausch & Lomb for failing to report the infection cases and also cited the company for several other health and regulatory violations. The agency also criticized Bausch & Lomb’s repeated assertion that until the ReNu recall, no link could be proven between ReNu with MoistureLoc and the Fusarium keratitis outbreak. “Your response states that this information did not reasonably suggest that ReNu with MoistureLoc multi-purpose solution device caused or contributed to the Fusarium infections,” the letter reads. “FDA disagrees.”