A Medical Device Daily

Bausch & Lomb (B&L; Rochester, New York) can’t seem to see the end to its lens solution problems.

Yesterday the company reported initiating a “limited” voluntary recall from distribution centers and retail shelves in the U.S. and several countries of 12 lots of ReNu MultiPlus lens care solution made at its plant in Greenville, South Carolina.

It said these lots contain “an elevated level of trace iron which may result in discoloration of the solution in some bottles, and the shelf life of the product may be shortened to less than its two-year expiration date, due to a potential loss of effectiveness over time.”

The company said it has received no reports of serious adverse events associated with these lots and that “virtually all of the affected product, manufactured about a year ago, has already been used by consumers.”

It said it notified FDA of the recall.

The company said 1 million bottles of solution from nine of the 12 lots were originally distributed in the U.S. Product from the 12 affected lots was also distributed in Canada, Latin America, Korea and Taiwan, where it is also being recalled.

The company said it investigated the matter after receiving three reports from customers of discolored solution. It then determined that the root cause was the elevated trace iron levels in a single batch of raw material, sourced from an outside supplier. It said that the elevated level of trace iron could combine with other compounds in the solution to cause discoloration, signaling that the solution may be losing effectiveness.

Angela Panzarella, VP and head of B&L’s global vision care business, said, “With detailed and specific information about the distribution of the affected product, and good information about consumer use patterns, we are highly confident that virtually all of the affected product was used before it began to lose effectiveness.”

She also expressed confidence that the source of the problem was identified “and we are taking appropriate measures designed to avoid a recurrence.”

The company said it did not expect that the recall would have any impact on its financials.