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FDA Warns Bausch & Lomb On Lens-Solution Infections |
By Patricia Kowsmann
November 7, 2006
Wall Street Journal
WASHINGTON -- Bausch & Lomb Inc. received a warning letter from the Food and Drug Administration, following an inspection of the company's Greenville, S.C., plant from March 22 through May 15. The inspection was in connection with reports that some users of Bausch & Lomb's ReNu with MoistureLoc contact-lens solution contracted a rare eye infection.
The Rochester, N.Y., company pulled the cleaning solution from world-wide markets in May after it said the product's formulation combined with certain use patterns likely contributes to an increased risk of Fusarium keratitis, a fungal eye infection that can lead to blindness.
The warning letter, dated Oct. 31 and addressed to company Chairman and Chief Executive Ronald L. Zarrella, reiterated preliminary findings the FDA reported in May. Like the preliminary report, the letter said the inspection didn't identify any conditions that contributed to or caused the infection, but it did find other problems.
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Some Bausch Solution Users Need Corneal Transplants After Infection |
By JENNIFER CORBETT DOOREN
August 23, 2006
One-third of patients with serious eye infections associated with a Bausch & Lomb Inc. contact-lens solution have had or are scheduled to have corneal transplants to repair the eye's outer surface damaged by the infections, according to research led by the Centers for Disease Control and Prevention.
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Lens Care Solution is Faulte |
By BARNABY J. FEDER
August 23, 2006
Federal disease control experts and leading eye doctors have formally concluded that ReNu With MoistureLoc from Bausch & Lomb was the only contact lens solution contributing to an outbreak of potentially blinding fungal eye infections earlier this year.
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Bausch & Lomb Solution Recall Exposes Risks for Eye Infections |
By SYLVIA PAGÁN WESTPHAL
July 26, 2006
Two months ago, Bausch & Lomb Inc. issued a global recall of a new multipurpose contact-lens solution after it was linked to serious fungal eye infections in the U.S. and Asia. Within weeks, the company's U.S. market share for lens solutions dropped to 29%, down from 41%.
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Contact-Lens Hygiene Problems |
By JON KAMP
June 28, 2006
Contact-lens wearers in Singapore who had serious fungal eye infections mainly used a contact-lens solution by Bausch & Lomb Inc. that it later pulled from the global market, and the majority of cases involved poor lens hygiene, a study found. |
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Bausch Delayed Case Reports, FDA Says |
May 17, 2006
LA Times
from Bloomberg News
Bausch & Lomb Inc. delayed telling U.S. regulators about 35 cases of a blinding eye infection in Singapore linked to its recalled ReNu with MoistureLoc contact lens cleaner, the Food and Drug Administration said Tuesday...
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An Important Message from Bausch & Lomb |
Dear Loyal ReNu Consumer,
I want to report to you on an important action we are taking, why we are so, and what it means to you.
On April 13, we told you to stop using MoistureLoc contact lens solution. Today we have decided to recall this product throughout the world. We will not reintroduce it.
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Bausch Was Told of Infections By Hong Kong Officials In Fall
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April 27, 2006
Wall Street Journal
by Sylvia Pagan Westphal
Bausch & Lomb Inc. said Hong Kong health authorities notified it of eye infections in users of the company’s contact-lens solution in November 2005, several months before the company stopped selling the product there...
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Eye-Fungus Cases Reach 54; Probe Into Cause Continues |
April Journal/LA Times
The Center for Disease Control and Prevention confirmed 24 new cases of a serious eye-fungus in the U.S., and health officials said it may be a month before they complete an investigation into whether Bausch & Lomb Inc.'s ReNu with MoistureLoc contact-lens solution is connected. The CDC reported 54 confirmed cases of Fusarium keratitis, up from 30 two weeks ago...
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More Infections Possibly Linked to Lens Cleaner |
April Journal/LA Times
from Bloomberg News
U.S. Health officials said they were investigating an additional 67 cases of a potentially blinding eye infection that's been linked to a Bausch & Lomb Inc. cleaner for contact lenses withdrawn from stores last week.
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Bausch & Lomb Pulls Lens Cleaner |
April 14, 2006
Los Angeles Times
Associated Press
After two days in a tailspin, shares of Bausch & Lomb Inc. edged up Thursday as federal officials investigated whether its newest contact lens solution was to blame for a fungal eye infection that can cause blindness...
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Bausch Won’t Ship Cleaner for Lenses Amid Infections |
April 11, 2006
By SYLVIA PAGAN WESTPHAL and ANNA WILDE MATHEWS
from the Wall Street Journal Online
Bausch & Lomb Inc. will voluntarily stop shipping a contact-lens cleaning solution over concerns about an increasing number of rare and serious fungal eye infections tied to contact-lens use...
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Bausch & Lomb Offers Lens Solution Product Exchange In Singapore |
March 13, 2006
SINGAPORE (Dow Jones)--U.S. eyecare-product maker Bausch & Lomb Inc. (BOL) Friday said it will offer a two-week voluntary product exchange program for ReNu contact lens solution users in Singapore...
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Bausch & Lomb to compensate Singapore customers |
March 10, 2006
SINGAPORE, March 10 (Reuters) - Eye-care product maker Bausch & Lomb , which suspended sales of its ReNu contact lens solution in Singapore and Hong Kong last month, on Friday announced a compensation plan for customers in Singapore...
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Contact Lens Solution Linked to Eye Ailment |
From Associated Press
Bausch & Lomb halts ReNu shipments after federal officials report a possible connection to a fungal infection. The shares fall after hours...
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Bausch & Lomb halts contact lens solution sales in Hong Kong
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February 23, 2006
SINGAPORE (Reuters) - Eye-care product maker Bausch & Lomb has suspended sales of its ReNu contact lens solution in Hong Kong, less than a week after suspending sales in Singapore following reports of a series of eye infections...
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