Study suggests poor temperature controls to blame for ReNu infection outbreak

Monday, 17 November 2008

A new study has found that improper temperature control during the production of Bausch & Lomb’s ReNu with MoistureLoc contact lens solution may have been responsible for an outbreak of fungal eye infections among patients who used the product. The study also found that ReNu was less able to properly disinfect contact lenses after being exposed to high temperatures compared with several other contact lens solutions. Bausch & Lomb issued a ReNu recall in May 2006 after the contact lens solution was linked to an outbreak of the fungal eye infection Fusarium keratitis. More than 150 cases of Fusarium infections were identified in the U.S. by federal health inspectors. A Food and Drug Administration inspection of the plant where ReNu with MoistureLoc was manufactured cited Bausch & Lomb for inadequate temperature control of products produced there. According to the study in the Archives of Ophthalmology, bottles of ReNu with MoistureLoc that were stored at higher temperatures were 250% less likely to prevent growth of the Fusarium fungus than bottles that were stored at normal temperatures. The study also found that MoistureLoc showed the greatest decline in anti-fungal activity after being exposed to higher temperatures of the six contact lens solutions that were tested. Bausch & Lomb is facing nearly 1500 ReNu lawsuits filed by patients who alleged that their use of the contact lens solution caused them to develop serious ReNu side effects. A spokesman for the company says that it has already agreed to settlements with some of these patients.