B&L recalls second contact lens solution

April 1, 2007

Rochester, NY-Bausch & Lomb is voluntarily recalling about 1.5 million bottles of its contact lens solution (ReNu MultiPlus) after it discovered elevated levels of trace iron had caused some of the solution to discolor and lose effectiveness.

Rochester, NY-Bausch & Lomb is voluntarily recalling about 1.5 million bottles of its contact lens solution (ReNu MultiPlus) after it discovered elevated levels of trace iron had caused some of the solution to discolor and lose effectiveness.

Two-thirds of the bottles in the affected lots were distributed in the United States, whereas the remaining supply was distributed in Canada, Latin America, Korea, and Taiwan. No adverse reactions were reported. The solution was made in March 2006 at the company's plant in Greenville, SC.

Two customers in Taiwan and Korea reported in late December and early January that three bottles of the solution had discolored, said company spokeswoman Barbara M. Kelley. Bausch & Lomb tested retained samples and adjacent lots, ultimately tracing the problem to faulty raw material from an outside supplier, she said.

Although the discoloration gradually occurs about 8 to 12 months into the solution's 2-year shelf life, she said company studies have found that consumers typically use the product long before it would show signs of losing effectiveness.

"We are highly confident that in fact virtually all this product is out of circulation and was in fact used by consumers before this," Kelley said.

Christopher Cooley, a senior analyst with FTN Midwest Research, was not so sure. He said his industry trade sources indicate "unsold product may still exist at the retail chain level."

In his March 7 report, Cooley said he was maintaining his "neutral" rating on the company. He told Ophthalmology Times that he did not believe the recall would substantially affect the company. Kelly said the recall affects less than 1% of Bausch & Lomb's annual lens care production.

Coming less than a year after the company suffered a major recall of another contact lens solution (ReNu with MoistureLoc) after it was linked to an increase incidence of Fusarium keratitis (See the May 15, June 1, June 15, July 1, and Sept. 15, 2006, issues of Ophthalmology Times), the current recall is inauspicious, however. The solution formula ultimately was discontinued after 130 confirmed cases of fungal keratitis were reported and 37 patients required corneal transplants. That solution was manufactured at the same plant associated with the newest recall.

The current recall "only serves to undermine OD and potentially consumer confidence as well," Cooley wrote in his research report. He said he also anticipates that the company will have to offer heavy discounting to retain its position as the retail category leader, further damaging profits.

He said he predicts that the company will lose 1% share this year in a flat market and may not compete well against Advanced Medical Optics Inc.'s anticipated "next-generation" solution (Complete) later this year.

Kelley said she is optimistic that consumers and retailers will remain objective and see this recall as a separate and much less serious event. The company was not required to issue a public announcement of the recall for a Class II recall, she noted, but it wanted to be proactive.

"We immediately contacted our customers. They were all very appreciative of it," she said, adding that calls to the customer service center had increased for only about 3 days after the announcement. "The fact of the matter is that recalls of lots of products are certainly not an unheard of development in the health-care industry."