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Bausch & Lomb halts US shipments of lens solution

April 10, 2006

By Susan Heavey

WASHINGTON (Reuters) – Bausch & Lomb agreed to stop
shipping its ReNu MoistureLoc brand contact lens solution in
the United States after some users were diagnosed with a
serious eye infection, the Food and Drug Administration said on
Monday.

Bausch & Lomb suspended sales of all ReNu solutions in
Singapore and Hong Kong in February after reports of similar
infections, although the company later said that tests found no
evidence to suggest its products were the cause.

The FDA said 109 preliminary reports of a rare fungal
infection that may cause loss of vision had been reported to
the Centers for Disease Control and Prevention 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.

“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.

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 52-week low on Monday on the New
York Stock Exchange before closing down 0.4 percent at $57.44.
In after-hours trade, the shares fell more than 9 percent to
$52.12 on the Inet electronic brokerage before being halted.

The FDA said the eye care product maker was not pulling any
of its existing MoistureLoc product from U.S. stores but urged
the approximately 30 million Americans who wear soft contact
lenses to keep their hands and lens cases clean.

Bausch & Lomb said ReNu MoistureLoc generated U.S. sales of
approximately $45 million in 2005.

In late March, the company had said that its first-quarter
vision care revenues in the Asia region were expected to be
reduced by as much as $10 million compared with internal
expectations.

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 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, which include the Lens Plus brand, were safe. Alcon,
the maker of Opti-Free solutions, could not immediately be
reached for comment.

Fusarium infection may lead to vision loss requiring
corneal transplants, the FDA said. It 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.

Bausch & Lomb spokeswoman Margaret Graham told Reuters
there have been no reports in Japan and no reports in Europe.

“That’s part of the conundrum,” Graham said. Experts were
looking to find out what was different between markets and
particular patients, she said.

Graham said anecdotal evidence from Singapore’s Ministry of
Health was that the infections were more often seen in patients
who did not adhere to recommendations of hygiene and care of
contact lenses.

(Additional reporting by Martinne Geller in New York)


Source: reuters



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