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news.Bausch & Lomb has temporarily suspended US shipments of its contact lens solution ReNu MoistureLoc after an FDA report warned users may be at an increased risk of eye infection.
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A fungus, called Fusarium, is thought to cause the infection that has so far been found in 109 people and is being investigated by public health authorities in 17 US states.
Of the 30 patient cases fully investigated so far, 28 wore soft contact lenses, 26 of which reported using ReNu brand contact lens solution or a generic brand manufactured by Bausch. However, the FDA has not suggested a link between the outbreak and any particular product.
“This is a serious infection and soft contact lens users should be mindful of the potential to develop this problem,” said Dr Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. “We’re advising consumers to practice good basic hygiene and follow manufacturers’ instructions for proper use, cleaning and storage of their lenses, and report any signs of infection to their doctors.”
In February this year Bausch suspended sales of all ReNu in Singapore and Hong Kong following reports of a similar nature. The eye health company later said tests on the product found no evidence to suggest ReNu was the cause.
“The source of these infections has not been determined. Based on our extensive testing, analysis and further internal reviews, and communications with leading experts, the available scientific evidence does not establish any type of ReNu solution as a cause,” said Ronald Zarrella, chairman and CEO of Bausch.
Mr Zarrella also said that the company had withdrawn sales as a precautionary measure in the interests of public health while investigations continue.