Firm halts contact lens solution salesMay 16, 2006 | Boston Globe
Bausch & Lomb Inc. yesterday permanently halted worldwide sales of a contact lens solution that it linked to a rare fungal infection that can cause blindness.
The company last month voluntarily pulled the lens cleaner, ReNu with MoistureLoc, from stores nationwide. Yesterday, it urged consumers to switch to other products in its eye care line that use a different chemical formulation to kill fungi. At least eight people in the United States have undergone cornea transplants after the fungal infection caused irreparable damage; they are among 155 Americans known to have been affected.
ReNu with MoistureLoc has been used by 5 million people worldwide, including 2.3 million of the nation's 30 million contact lens wearers. Of 75 million bottles of the product in the hands of consumers, many are 2-ounce samples the company began distributing in 2004, when it launched the product.
The Food and Drug Administration told consumers to discard any unused solution.
Ronald Zarrella, Bausch & Lomb's chief executive, told analysts that neither the Rochester, N.Y. company nor the FDA has linked the unusual spike in fungal infections to its other contact lens solutions. The company recommends retailers instead stock Bausch & Lomb's Renu MultiPlus, a cleaning solution already used by 11 million Americans. About 25 percent of the nation's contact lens wearers use some kind of Bausch & Lomb cleaner.
''We're quite confident of the health and safety of MultiPlus and our other products," Zarrella said during an investors' call. The company said the cost of the recall and lost sales will total about $170 million. That estimate does not include advertising and other costs associated with rebuilding the brand. Nor does it factor in product liability lawsuits that are typically filed after such market withdrawals.
The size of the recall is dwarfed by Merck & Co.'s decision in 2004 to pull Vioxx, a blockbuster painkiller that had been used by millions. But Bausch & Lomb's admission that its own solution may be to blame for potentially blinding infections is expected to raise its legal liability to as high as $1 billion.
Yesterday's recall followed weeks of federal and internal company investigations into a possible link between ReNu with MoistureLoc and infections caused by the Fusarium keratitisfungus. Those can cause blurred vision, redness and pain that does not improve when the contact lens is removed, increased sensitivity to light, and excessive tearing. Without treatment, the infection can scar the cornea and can cause blindness.
ReNu with MoistureLoc leaves the Greenville, S.C., factory where it is manufactured with ''satisfactory" fungicidal properties, said Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health.
Zarrella said the product's unique chemical composition helped to create a ''perfect storm" that increased consumers' odds of getting fungal infections. Something as simple as leaving the bottle's flip top open or ''topping off" lens cases with solution could allow the fungus to grow.
As the solution evaporated, it developed a thin film that protected the fungus, allowing it to ''basically hide from" disinfectant in the lens solution that otherwise would have killed it, Zarrella said.
The MultiPlus product, which cleans, rinses, and disinfects soft contact lenses, uses a different combination and concentration of chemicals, a company spokeswoman said.
Yesterday's disclosures by the FDA and the company rules out manufacturing difficulties as causing the infection, at least for now. That ''solidifies the consensus" that the problem is the solution itself, said Joseph Saunders, a Florida attorney who has already sued the company on behalf of an elderly woman who allegedly lost 80 percent of her vision in one eye due to the fungal infection.
Investors reacted favorably to news that the infection risk is limited to one cleaning solution. They traded 15 milllion shares of the company's stock yesterday, sending shares soaring to $50.08, up 12.7 percent, at market's close.
Bausch & Lomb acted one day before the anticipated release of a FDA inspection report on problems at the Greenville plant. The FDA has had up to as many as four inspectors at the plant for the past two months.
The company yesterday said it corrected many of the packaging and sterilization problems as inspectors pointed them out.
''They should not impact our ability to run the plant," Zarrella said.
The South Carolina facility was the subject of a 2002 warning letter from the agency that detailed manufacturing problems, including Bausch & Lomb's inability to show that the finished product contained appropriate amounts of disinfectant, and the presence of flaking ceiling paint in rooms where sterile eye care products were produced.
The company was first alerted to the fungal infection link by authorities in Asia in February. In early March,a New Jersey ophthalmologist reported three cases of the fungal infection to the Centers for Disease Control. One month later, that figure grew to 109 Americans with suspected infections. By May 12, the CDC reported 122 confirmed cases, 15 suspected infections and another 60 cases under investigation.