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03-06-07, 09:53 PM #1
Bausch & Lomb recalls contact lens solution AGAIN
More bad news for ReNu users...
Another Contact Lens Solution Recalled
(AP) Bausch & Lomb Inc., already humbled by a worldwide recall of its ReNu with MoistureLoc contact lens solution, said Tuesday it is recalling about 1.5 million bottles of ReNu MultiPlus because trace amounts of iron could cause the cleaner to lose effectiveness earlier than normal.
The optical products maker also reported a modest drop in fourth-quarter and full-year sales in 2006, 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 believes 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, 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," company spokeswoman Barbara Kelley 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.
Last May, Bausch & Lomb permanently withdrew its new-formula MoistureLoc multipurpose cleaner from markets around the world when federal regulators called the product the "potential root cause" of an outbreak of Fusarium keratitis infections.
A cluster of the potentially blinding infections surfaced in Asia in fall 2005, and an unusual number of victims began showing up in U.S. eye centers last winter. The company stopped selling MoistureLoc in Hong Kong and Singapore in February 2006 but didn't halt U.S. shipments until April.
Lawyers expect several hundred people will seek damages for Fusarium keratitis infections in trials beginning as early as this summer. Of the 180 infection victims confirmed so far in 35 states, 59 needed cornea transplants to try to restore their vision, the Centers for Disease Control and Prevention in Atlanta said. Several people allege the MoistureLoc solution caused them to lose an eye.
The company advised consumers to discard bottles of the affected solution if it appears to be discolored as it may be losing effectiveness. It said the recalled lots carry the expiration date "2008 — 03" on the bottle.
Separately, the company said revenue for 2006 dropped 3 percent to about $2.29 billion. It expects to report fourth-quarter revenue of about $598.5 million, down 5 percent from $626.4 million in the year-ago period, or 7 percent on a constant-currency basis.
Since Bausch & Lomb has yet to close its accounting process for the year, it cannot estimate earnings per share, but reiterated it expects U.S. operations to be unprofitable because of the recall.
Analysts surveyed by Thomson Financial expect quarterly earnings per share of 27 cents on higher revenue of $619.7 million, and 71 cents per share on revenue of $2.32 billion for the year.
The company says consumers who have bottles from the lot numbers listed below should check its Web site or call the consumer affairs line at 1-866-259-8255 to arrange for a replacement.
Lot numbers subject to recall are: GC6030 — GC6037 — GC6038 — GC6045 — GC6048 — GC6052 — GC6061 — GC6063 — GC6072 — GC6073 — GC6080 — GC6085.Alpha Phi Sigma Alum - Alpha Delta Chapter
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