Persons using Bausch & Lomb's ReNu with MoistureLoc contact solution with their soft contact lenses are at risk of developing fungal keratitis infections from the Fusarium fungus, a rare but serious and painful eye infection that can cause permanent blindness or significant loss of vision. On April 13, 2006, Bausch & Lomb asked US Retailers to remove ReNu with MoistureLoc from their shelves, while the FDA and the Centers for Disease Control (CDC) investigated at least 109 suspected cases. On May 15, 2006, the FDA and Bausch & Lomb permanently withdrew the product. The FDA completed its investigation of Bausch & Lomb's manufacturing plant in Greenville, SC, where US supplies of the solution were manufactured, and reported more than 20 violations in is manufacturing process.
Bausch & Lomb now faces at least 400 consumer product liability lawsuits in the US from victims claiming injury from Renu, and it also faces lawsuits from shareholders. One suit alleges that the product was "unreasonably dangerous and defective" due to contamination and that Bausch & Lomb failed to warn consumers of the dangers associated with the product. The plaintiff suffered extreme pain and anguish and was hospitalized. She now faces additional upcoming surgeries to possibly remove her eye.
The lawsuit further claims that Bausch and Lomb committed acts of negligence through failing to remove the product from the market; continued to market and sell ReNu with Multiplus; failed to warn of all possible side effects and misrepresented and concealed the possible risks or dangers of use. As well, the manufacturer is also accused of strict liability through design, manufacture, and marketing defects and breach of express and implied warranties.
Another suit claims that the FDA notified the healthcare industry about a recall of the product in November of 2006 but did not remove the product from stores. However, in the wake of countless contact lens solution users suffering potentially blinding eye infections, the agency is finally conducting a safety review and will convene a panel of experts this June, 2008 to "discuss general issues" with various lens cleaners and determine whether new testing or package labeling should be required.
Bausch & Lomb, based in Rochester, NY, was acquired by private-equity firm Warburg Pincus LLC in October, 2007. Analysts estimate that Bausch & Lomb could face potential liabilities of $1 billion plus over Renu lawsuits.