Monthly Archives: May 2006

China FDA Removes ReNu from Stores

The Shanghai Food and Drug Administration has removed all US manufactured ReNu with MoistureLoc products from store shelves. Only about 2% of the ReNu product is made in the US. The majority of the product is made domestically. Bausch & Lomb has tried to assuage Chinese consumers that since the bulk of the ReNu they use is produced in China, it’s safe for use.

Source of Fusarium Keratitis Fungus Still a Mystery

According to an article in the NY Times, a researcher hired by Bausch & Lomb has published a report indicating that the infection is not coming from the eye contact solution. The FDA and CDC have not commented directly on his findings. FDA officials declined to comment yesterday on Mr. Geiser’s assessment. But the agency’s Web site posted an update saying that while it continued to confirm cases of Fusarium infections associated with products other than ReNu With MoistureLoc, “Our interest in the MoistureLoc product is based on the disproportionate number of cases of Fusarium keratitis associated with ReNu With MoistureLoc compared to the overall product market share.”
As of yesterday, the federal Centers for Disease Control and Prevention in Atlanta had received 195 reports of Fusarium eye infections occurring in the United States since last June, 102 of which had been confirmed in follow-up investigations. “At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak,” the C.D.C. said.

Bausch & Lomb Fungus Enters Europe

New cases of the fusarium keratitis fungus have been confirmed in Europe. The cases represent the first time the company has acknowledged European incidents of the infection, which has struck Bausch solution users in Asia and the U.S. The outbreak has led the company to halt shipments of one of its products, ReNu with MoistureLoc, in several countries and to scrutinize a manufacturing plant in South Carolina for a possible explanation of the infection.

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Bausch & Lomb’s “Perfect Storm”

The “Perfect Storm” analogy are not my words but the words of Bausch & Lomb Chief Executive Ron Zarrella. He made the comments in the wake of a CDC investigation that seems to point more significant blame on Bauch & Lomb eye solution products than first thought. It may be that all Bausch & Lomb eye solution products are suspect in the wake of the fungal fusarium keratitis outbreak. Here’s Ron Zarrella unplugged: “We’re looking at every possibility,” Chief Executive Ron Zarrella said in a videotaped message posted on the company’s Web site. “Some of our experts believe it’s possible that a number of factors could have come together to create a kind of perfect storm to allow this fungus to take hold.”

Sites Set on Bausch & Lomb

As the days pass, the news continues to get worse for Bausch & Lomb. Initially, the company asked consumers to stop using one of their products, ReNu with MoistureLoc. In the intervening weeks, company execs tried to intimate that if there was a problem at all, it was restricted to the one product. Now that the CDC report comes out we know otherwise. Let’s take a look a the CDC numbers:
Fusarium Keratitis Outbreak among contact users:
56 confirmed cases
32 – B & L ReNu with Moisture Loc
15 – B & L ReNu with MultiPlus
7 – B & L ReNu (unspecified)
6 – other company brands
-Source US CDC

More Tears for Bausch & Lomb

In a company press statement issued in the middle of the night, Bausch & Lomb now reveal that additional cases of fusarium keratitis have been linked to the company’s ReNu products. According to a Market Watch report, “In an overnight release, Bausch & Lomb said “that a review by the U.S. Centers for Disease Control and Prevention had found reported cases of fungal keratitis among contact-lens wearers who used not only ReNu with MoistureLoc but also another popular ReNu product, ReNu MultiPlus solution.”