Bausch & Lomb Recalls ReNu Contact Lens Solutions in Europe, Middle EastJul 12, 2010 | Parker Waichman LLP
Bausch & Lomb is recalling certain lots of its ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East. The company characterized the action as “precautionary”.
The recall involves two separate actions. The first includes a single lot (AA120) of 120ML ReNu MultiPlus multi-purpose solution in Croatia, Dubai, Hungary, Slovenia, Romania, Turkey and Saudi Arabia. According to Bausch & Lomb, it has received a small number of reports about sensitivity issues related to this lot. The company did not specify how many reports had been received.
In a separate action, Bausch & Lomb is also voluntarily recalling a limited number of lots of its ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East.
“Routine testing has shown that while these products are safe and effective when used as directed, they are not meeting our quality expectations,” the company said in a statement. “We decided to initiate the quality-related recall after our Stability Monitoring Program showed that the performance trend of certain lots did not meet our expectations. There is no indication of a safety or efficacy issue and there have been no reported adverse events; rather, this recall is being conducted as a precaution.”
This is not the first time that Bausch & Lomb has conducted a recall of a ReNu product. Bausch & Lomb pulled ReNu with MoistureLoc from Asian markets in February 2006, and did the same in the U.S. in April of that year, after it was linked to an outbreak of Fusarium keratitis, a potentially blinding eye infection. The company would ultimately issue a worldwide recall of ReNu with MoistureLoc on May 15, 2006.
A U.S. Centers for Disease Control (CDC) report on the outbreak found that those infected with Fusarium keratitis were 20 time more likely to have used the ReNu with MoistureLoc solution. The CDC report determined that bad hygiene habits among users were not to blame for the infections, but that the contact lens solution appeared to have poor disinfectant qualities. The CDC ultimately confirmed 180 cases of Fusarium keratitis in the U.S. According to the Associated Press, at least 60 more Americans needed vision-saving corneal transplants.
The ReNu with MoistureLoc debacle spawned nearly 2,000 personal injury lawsuits.