Bausch & Lomb Received A Letter From FDA Regarding Its Quality Control Problems. This week, Bausch & Lomb received a condemnatory letter from the FDA regarding the manufacturing conditions at one of its plants, where an inspection revealed several quality control problems. The inspection stemmed from an incident this year where one of the company’s contact lens solutions, ReNu MoistureLoc, was linked to more than a hundred cases of Fusarium keratitis, a rare and potentially blinding fungal eye infection. The letter condemned manufacturing practices as well as the company’s response to the issue.
Infections Outbreaks In Connection with MoistureLoc Product
As a result of the outbreak, several people received cornea transplants to save their eyesight, while many more narrowly escaped the same fate. However, the most troubling aspect of this incident isn’t a few cornea transplants – it’s that Bausch & Lomb waited several months before doing anything about it. The rise of infections in the United States was preceded by dozens of infections in other countries. Singapore, Malaysia and Hong Kong all reported similar outbreaks in connection with the MoistureLoc product. And surprisingly, months before the product was pulled from the shelves in the United States, it was pulled from the shelves in each of these three countries. Then, after the infections received attention here, Bausch & Lomb decided to halt shipments of the product and recall it entirely.
Would they have pulled the product at all if our country hadn’t uncovered the problem? The thought is troubling enough. Three discrete instances of the outbreak weren’t sufficient to warrant this action, so it’s no stretch to imagine that similar outbreaks would have occurred in other countries without our intervention.
Luckily for those affected, there is a way to seek justice. And as much as we love to bash lawyers in this country, they’re the people delivering it. The number of lawsuits prompted by this incident will provide enough punishment so that this company and others will rethink their crisis response strategies. We can only hope that if Bausch & Lomb was responsible, then the litigants who lost their eyesight or nearly did take this company to the bank.