Bausch & Lomb announced today that it is recalling 1.5 million bottles of ReNu MultiPlus contact-lens solution because trace levels of iron were found in the product. Iron may cause “discoloration” of the solution and may cause its effectiveness to deteriorate before the printed expiration date.
The recall affects 12 lots of the product, which were produced at the company’s Greenville, S.C., plant and sold in the U.S., Canada, Latin America, Korea, and Taiwan. “The company initiated an investigation after receiving three customer reports of discolored solution,” Bausch & Lomb said in a statement. “The root cause of the discoloration was determined to be an elevated level of trace iron in a single batch of raw material sourced from an outside supplier. The elevated level of trace iron could combine with other compounds in the solution to cause discoloration, which signals that the solution may be losing effectiveness over time.”
The company stressed that the latest recall was unrelated to the earlier recall of ReNu with MoistureLoc, which was associated with an outbreak of the severe fungal eye infection known as Fusarium keratitis. The company suspended Asian sales of ReNu with MoistureLoc in February of 2006 and U.S. sales in April of that year, although it wasn’t until the following month that Bausch & Lomb announced a full global recall and permanent withdrawal of the product from shelves in the face of mounting evidence from the U.S. Centers for Disease Control and Prevention (CDC) and others that the product carried a significant risk of the infection, which can cause permanent damage including blindness.
