- The Washington Times - Tuesday, March 6, 2007

ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc., already humbled by a worldwide recall of its ReNu with MoistureLoc contact-lens solution, said yesterday it is recalling about 1.5 million bottles of ReNu MultiPlus solution because trace amounts of iron could cause the cleaner to lose effectiveness sooner than normal.

The optical-products maker also reported a modest drop in fourth-quarter and full-year sales last year, citing sluggish contact-lens sales amid a slower-than-expected recovery from last spring’s recall of MoistureLoc, which was blamed for an outbreak of severe fungal eye infections.

The company said it has carried out a limited voluntary recall of 12 lots of its ReNu MultiPlus solution after getting three customer reports of discolored solution.

No one was reported hurt, and the company thinks that virtually all of the solution, made about a year ago at its plant in Greenville, S.C., has already been used by lens wearers.

About a million bottles of the popular brand were distributed in the United States and another 500,000 in Canada, South Korea, Taiwan and Latin America. The company has notified the Food and Drug Administration and regulators in the other affected countries of the recall.

“I want to emphasize that this is completely unrelated to and different from the MoistureLoc recall,” a spokeswoman said.

“There have been no serious adverse events associated with this occurrence, and the possibility of a serious adverse event is remote.”

Bausch & Lomb determined the discoloration was caused by trace amounts of iron found in a single batch of raw material from an outside supplier. As a result, it said, the affected lots could have a shorter shelf life than the two-year expiration date.

“From what they’re describing, the event that occurred was relatively minor,” said Dr. Penny Asbell, a professor of ophthalmology at Mount Sinai School of Medicine in New York. “It’s definitely a different story from MoistureLoc. We now understand that certain conditions led that solution to be a very poor disinfectant. And it seems obvious now, but quite honestly, it wasn’t obvious at the time.

“The take-home message from this event is most people do very well with contact lenses, but there are some risks, and they can cut down those risks by following the manufacturers’ recommendations. One thing they often don’t realize is not only does the bottle have a shelf life in the store, it has a shelf life once it’s opened, which is under their control.”

Of the more than 30 million Americans who wear contact lenses, about 2.3 million used MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales in 2005. At least 11 million people use the MultiPlus solution, which was launched a decade ago.

The company says consumers who have bottles from the lot numbers listed below should check its Web site at www.bausch.com/productrecall or call the consumer affairs line at 866/259-8255 to arrange for a replacement.

Lot numbers subject to recall are: GC6030 - GC6037 - GC6038 - GC6045 - GC6048 - GC6052 - GC6061 - GC6063 - GC6072 - GC6073 - GC6080 - GC6085.


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