When eye infections may be caused by a contact lens solution the manufacturer of the solution has to blink. That is just what Bausch & Lomb did when the real possibility of a link between its contact lens solution, ReNu, and a serious eye infection was raised. The manufacturer has stopped the sale of its product while the investigation by the FDA continues. Vision loss can be the end result of the eye infection implicated by FDA case reports.
Bausch & Lomb halts shipments of ReNu
WASHINGTON (Reuters) – Bausch & Lomb has stopped shipping its ReNu brand contact lens solution after a number of people using the product reported getting a serious eye infection, the Food and Drug Administration said Monday.
The FDA said that 109 cases of the rare but serious infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17 U.S. states. But the agency said during a conference call that it was not aware of a link between the infection and specific products.
The FDA said it had completed cases on 30 reports. 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.
“Bausch & Lomb’s first priority is the health and safety of consumers,” said Ronald L. Zarrella, chairman and CEO of the company. “The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data.”
The infection, caused by the Fusarium fungus, may lead to vision loss requiring corneal transplants, the FDA said.
The FDA and CDC are investigating the reported cases. The company says it is collaborating with agencies in the investigation.
An InjuryBoard.com overview of this topic is available.
When eye infections may be caused by a contact lens solution the manufacturer of the solution has to blink. That is just what Bausch & Lomb did when the real possibility of a link between its contact lens solution, ReNu, and a serious eye infection was raised by the FDA. The manufacturer has stopped the sale of its product while the investigation by the FDA continues. Vision loss can be the end result of the eye infection implicated by FDA case reports.
Bausch & Lomb halts shipments of ReNu
WASHINGTON (Reuters) – Bausch & Lomb has stopped shipping its ReNu brand contact lens solution after a number of people using the product reported getting a serious eye infection, the Food and Drug Administration said Monday.
The FDA said that 109 cases of the rare but serious infection that may cause loss of vision had been reported to the Centers for Disease Control and Prevention (CDC) from 17 U.S. states. But the agency said during a conference call that it was not aware of a link between the infection and specific products.
The FDA said it had completed cases on 30 reports. 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.
“Bausch & Lomb’s first priority is the health and safety of consumers,” said Ronald L. Zarrella, chairman and CEO of the company. “The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data.”
The infection, caused by the Fusarium fungus, may lead to vision loss requiring corneal transplants, the FDA said.
The FDA and CDC are investigating the reported cases. The company says it is collaborating with agencies in the investigation.
An InjuryBoard.com overview of this topic is available. .
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