Medical Device Daily Associate

Bausch & Lomb (B&L; Rochester, New York) reported on Monday that it has extended a recall of its ReNu with MoistureLoc contact lens solution to all markets worldwide, saying the product may increase the risk of a potentially blinding eye infection called Fusarium keratitis.

In a conference call on the worldwide recall, B&L said some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in “unusual circumstances.”

B&L Chairman and CEO Ronald Zarrella noted during the call that company testing has revealed that several strains of the virus have been detected, thus indicating that there is no one primary source involved here, and that there is not an “unknown [new] genotype” involved in the reported cases.

He said that the company's probe found “no evidence of product contamination, tampering, counterfeiting or sterility failure.”

“What became apparent is that the operative theory at this point, and the one that the FDA and leading eye care experts agreed with is that these remaining factors have combined to create a perfect storm of circumstances,” said Zarrella. “In other words, no one factor could overwhelm the solution, but when they come together in unique circumstances, it's quite possible the risk of infection increases,” he added.

Among some of the “perfect storm” factors Zarrella noted were the formulation of MoistureLoc itself, environmental conditions and lens wearer care practices.

Zarrella noted that the fungus is commonly found in plant material and soil in tropical and subtropical areas, with strains often showing up in sinks, drains or bathrooms where people handle their lenses. Without treatment, which can last two to three months, the infection can scar the cornea and potentially blind its victims.

The company had already pulled the product in the U.S. last month (Medical Device Daily, April 16, 2006) and parts of Asia earlier this year after it was linked to a rash of the fungal infections. On May 4, B&L said a “handful” of cases of the infection have been confirmed in Europe.

The sharp rise in infections brought a flurry of product-liability lawsuits, including one from a woman in Florida who alleged that the solution caused her to lose an eye, and at least eight other people underwent cornea transplants.

Separately, the FDA said on Monday it supported the company's recall of the MoistureLoc brand.

The FDA in a conference call said the Fusarium outbreak appears to be related to the design and use of B&L's ReNu with MoistureLoc formula.

Daniel Schultz, MD, director of the FDA's Centers for Devices and Radiological Health, said the inspection of the Greenville, South Carolina, plant did turn up a number of problems with the manufacturing practices at the facility that were unrelated to the outbreak.

“Based on the understanding we have now, there are a large number of factors that sort of have to come together for this to come into play,” said Schultz. “That is what makes this more different than your average user-error scenarios.”

Schultz said agency will issue its report on the manufacturing facility n the next few days, but he downplayed the significance of any manufacturing issues.

Based on ways the solution is handled, its otherwise acceptable fungicidal properties “can deteriorate to the point where they no longer prevent the growth of this fungus in and around the [lens] case,” Schultz said. Infections, he added, may involve contamination with “other material” that occurs in the environment.

Authorities in Singapore had earlier linked a number of cases of the same infection to use of a B&L ReNu solution, and Hong Kong had asked the company to pull ReNu from store shelves, although testing did not show a problem.

The company said the MoistureLoc recall, effective immediately, extends even to countries where the company has seen no unusual trends in Fusarium infections, including China, Europe, the Middle East, and Africa.

The company recommended that former MoistureLoc users switch to ReNu MultiPlus or ReNu Multi-Purpose, which have a different formula from that of MoistureLoc.

The company noted that manufacturing plants in Greenville, South Carolina; Milan, Italy; Bhiwadi, India and Beijing will shift production from MoistureLoc to the ReNu MultiPlus and ReNu Multi-Purpose formulas.

The FDA said data so far did not indicate problems with ReNu MultiPlus or ReNu Multi-Purpose brands.

Bausch's MultiPlus brand, however, has also been linked with the fungal infection in reports by the U.S. Centers for Disease Control and Prevention (CDC; Atlanta).

The brand makes up 20% of confirmed cases among contact lens wearers that the CDChas evaluated.

The CDC said the number of confirmed cases of Fusarium keratitis in the U.S. has climbed to 122, most of them contact-lens wearers who reported using MoistureLoc.

First Albany Capital (New York) healthcare analyst Jason Mills wrote in a report that he is concerned that the ReNu-related infection issue “could get worse before it gets better.” He also suggested that the company should have been more proactive and implemented the worldwide recall “weeks ago.”

Of the more than 30 million Americans who wear contact lenses, about 2.3 million use MoistureLoc, which was introduced in late 2004 and accounted for $100 million in global sales last year. Another 11 million people use the MultiPlus solution.