April 11, 2006
Bausch & Lomb Curbs Shipments After Eye Infections
By Susan Heavey
WASHINGTON -- Bausch & Lomb agreed to stop shipping its ReNu MoistureLoc brand contact lens solution after some users reported getting a serious eye infection, the U.S. Food and Drug Administration said on Monday.
The FDA said 109 preliminary reports of the rare fungal infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17 U.S. states.
The agency said it was not aware of a direct link between the Fusarium fungus and any specific product, but in 26 cases so far, patients used Bausch & Lomb's ReNu MoistureLoc solution.
Bausch & Lomb Chairman and Chief Executive Officer Ronald Zarrella called the data "troubling and perplexing, as there is an apparent disproportionate representation of U.S.-manufactured ReNu with MoistureLoc."
The halt in shipments was a further blow to Bausch & Lomb which said last month it was delaying issuing its 2005 annual report amid internal accounting investigations.
The company's shares hit a new 52-week low on Monday on the New York Stock Exchange and fell further in afterhours trade on Inet electronic brokerage before being halted.
The suspension of U.S. shipments follows reports in February of similar infections in Asia. Bausch & Lomb said in late March that tests found no evidence to suggest its products were the cause.
The FDA said the eye care product maker was not pulling any its existing MoistureLoc product from U.S. stores. Bausch & Lomb said the product generated U.S. sales of approximately $45 million in 2005.
"We do not at this point have information that gives us a direct cause-and-effect link between any particular product or any particular action," Dr. Daniel Schultz, head of FDA's Center for Devices and Radiological Health, told reporters on a conference call.
U.S. health officials have complete information for 30 reported cases. Of those, 28 people wore soft contact lenses, and 26 of them reported using a Bausch & Lomb's ReNu brand in the month before the infection.
Five patients reported using other solutions in addition to ReNu, including some made by Advanced Medical Optics Inc. and Alcon Inc.. An Advanced Medical Optics spokesman said its products were safe. Alcon could not immediately be reached for comment.
Fusarium infection may lead to vision loss requiring corneal transplants, the FDA said.
There are about 30 million Americans who wear soft contact lenses, and agency officials urged them to keep their hands and lens cases clean.
They also asked doctors to be vigilant when testing patients who contract any eye infection.
FDA's Schultz said the agency was not made aware of the CDC's data on U.S. cases until March 8. Both agencies are investigating the 109 reported cases, which occurred between June 15, 2005 and March 18, 2006.
Tim Ulatowski, head of compliance for the FDA's device center, said agency inspectors have already been to Bausch & Lomb's manufacturing plants and warehouses testing various samples. He said the inspections should be completed within days.
Shares Bausch & Lomb were halted in afterhours trading after falling more than 9 percent to $52.12 on Inet. They earlier closed at $57.44 on the New York Stock Exchange.
(Additional reporting by Martinne Geller in New York)