May 17, 2006 FDA finds Bausch and Lomb didn't follow the rules. FDA says 35 cases were not
reported properly. Bausch & Lomb denies the allegations and said it
communicated promptly and directly with the FDA regarding reports the company
received about fusarium infections. On Tuesday, the FDA released the findings of
an inspection team that was at the Greenville plant from March 22 until May 15.
In a report, the team faulted Bausch & Lomb in 20 procedural areas. Inspectors
said Bausch & Lomb failed to:
Do a complete design plan for the
ReNu with MoistureLoc product.
Follow procedures to prevent
contamination of equipment and product.
Properly define and document
procedures for controlling environmental conditions.
Implement procedures to control
storage of product in storage areas and stock rooms.
Conduct quality control audits.
Implement procedures to prevent
problems during handling of product.
Ensure appropriate design,
construction, placement, and installation of manufacturing equipment.
Properly document maintenance
activities.
Still, the FDA said that while the
team's observations at the plant may indicate deviations from current good
manufacturing practice, they do not necessarily support a connection between
ReNu with MoistureLoc and the fungal infections.
May 15, 2006
Bausch Lomb is permanently removing its Greenville-made ReNu with
MoistureLoc Baush and Lomb contact lens solution from the worldwide market after concluding
the product's formula may increase the risk of fungal eye infections in certain
unusual circumstances. Problems with the solution were reported in the United
States, Singapore, Hong Kong, and Malaysia -- all markets served by the
Greenville plant. The U.S. Food and Drug Administration dispatched a team of
investigators to the plant March 22, and on April 10, Bausch Lomb said it had
stopped shipments of ReNu with MoistureLoc from the plant. The company and the
FDA said they believe they've solved the mystery and that it lies in the
chemical properties of ReNu with MoistureLoc in the manufacturing process at the
Greenville plant. Exhaustive testing revealed that ReNu with MoistureLoc, under
certain conditions, such as if the bottle cap is left open, allows a polymer
film to form, and the Fusarium fungus, found just about everywhere, can survive
on the film, insulated from alexidine, the disinfectant in ReNu with MoistureLoc.
The fungal infections appear to be related to the design of this particular
solution and don't stem from a problem with the manufacturing and the way in
which the product leaves the facility.
April 20, 2006 Bausch Lomb class action lawsuits likely in multiple states. In Miami, an attorney is seeking class action status for a lawsuit against Bausch & Lomb for ReNu eye infections. The lawsuit alleges that plaintiffs have suffered painful eye fungus injections. These infections permanently scarred the cornea of the Bausch Lomb class action plaintiff, a woman who used its contact lens solution. The lawsuit follows a similar Bausch & Lomb class action suit filed in New York, that also alleges the company failed to remove the fungus from the Renu with MoistureLoc eye solution and/or caused the fungus to grow in the manufacturing process.
April 15, 2006 The company asks retail stores to take ReNu with MoistureLoc Bausch and Lomb contact lens
solution made in the Greenville plant off the shelves temporarily but did
not request that the solution be returned to the company. CEO Ron Zarrella said
neither the company nor the FDA had discovered contamination at the plant after
nearly three weeks of testing. The company's request that retailer pull its
product did not apply to other Bausch & Lomb products or ReNu with MoistureLoc
made outside the United States. The request came as several U.S. retailers led
by Wal-Mart., Walgreen, and CVS Corp., were pulling the ReNu Bausch and Lomb contact lens solution with MoistureLoc
solution off their shelves on their own.
The company stopped shipments of MoistureLoc in the United States when the CDC
said it was scrutinizing 109 reports of fungal keratitis infections in patients
in 17 states over the past 10 months.
April 12, 2006 Bausch & Lomb said that neither the company nor any of the five federal
inspectors had found any evidence that contact lens solution made at its
Greenville plant is connected to eye fungus infections after nearly three weeks
of testing. The company also doesn't have any plans to furlough or lay off any
of the approximately 450 workers at the Pelham Road facility, even though it
halted shipments of solution made there. CEO Ron Zarrella said that tests have
been conducted on samples of solution made at the plant, solution from store
shelves, and solution used by victims who became infected and none have revealed
evidence of the fungus. He said test results of swabs taken in non sterile areas
of the plant aren't back from labs, but it won't be surprising if they are
positive because the Fusariam fungus is found just about everywhere. Zarrella
told analysts the company is ramping up production of another contact lens
solution now that some retailers are pulling ReNu with MoistureLoc from their
shelves but it wasn't immediately clear how that might affect the Greenville
plant.
April 12, 2006 Singapore: 36 more cases of fusarium keratitis reported since the last update
in late February (then 39 cases). In total, 75 cases of fungal corneal infection
with a history of contact lens use have been reported.
April 10, 2006 Bausch & Lomb stopped shipping product to U.S. stores but said stores could
continue to sell existing product until supplies ran out. "There's no
indication there is a formula problem here," CEO Zarrella said.
March 31, 2006 Bausch and Lomb is collaborating in a surveillance program and scientific
investigation to track and investigate the incidence of the infection with
health authorities and leading experts around the world including the United
States.
March 22, 2006 FDA begins inspection of Bausch & Lomb, Greenville, S.C. plant.
March 18, 2006 Eight victims required corneal transplants to avert blindness. Only 30
cases investigated thus far. Of those 30 cases, 28 wore soft contacts and all
but two used ReNu products. Five of the 26 who used ReNu also used other
solutions.
March 8, 2006 A New Jersey ophthalmologist reports three cases of rare fungal infection,
fusarium keratitis to the CDC within the last three months. The U.S.
investigation begins.
February 20, 2006 Bausch Lomb voluntarily suspends sales in Singapore, Malaysia, and Hong Kong
after 29 cases of fungal keratitis are found in Asia since November 2005.
December 2005 Bausch & Lomb mentions but downplays the Hong Kong incident to the FDA.
November 2005 Hong Kong health officials tell Bausch & Lomb about the noted increase in
hospital admissions due to contact-lens-related keratitis from June to September
2005.
June 15, 2005 First reported fusarium case reported in the United States
Why did Bausch & Lomb take so long
to warn the public about possible ReNu problems?
Do you need to participate in the Bausch Lomb Class Action?
