Bausch Issues Worldwide Recall of Contact Lens Cleaner
By BARNABY J. FEDER
Published: May 15, 2006
Bausch & Lomb said today that it had issued a worldwide recall of its ReNu With MoistureLoc soft contact lens cleaner because its testing suggested the product does not consistently protect lens wearers from a potentially blinding fungal infection.
Bausch said its continuing investigations and those of government health authorities provided no basis so far for believing that the problems extend to its other ReNu products. As a result, Bausch will step up its marketing of ReNu MultiUse cleaner and other ReNu-brand lens products, according to Ronald Zarella, the company's chairman and chief executive.
The Food and Drug Administration endorsed Bausch's recall and said that although a thorough review of Bausch's manufacturing plant in Greenville, S.C., had turned up some violations of manufacturing practices that the agency will disclose later this week, none of the infractions appeared to be linked to the problems with MoistureLoc. The infection outbreak, which involves the Fusarium fungus, has for the most part been confined to the United States and several Asian countries that Bausch supplies from Greenville.
While some reports of fungal eye infections have come from users of other products, regulators say MoistureLoc has been the only product where the number of Fusarium cases reported is far higher than might be expected in normal circumstances. As of last Friday, the Centers for Disease Control had reported 122 confirmed Fusarium cases among soft contact lens users since last June, with about two-thirds being linked to MoistureLoc....
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Bausch, which is based in Rochester, N.Y., said it had concluded by early last week that MoistureLoc's formulation might raise the risks of eye infections from the Fusarium fungus when contact lens users follow practices like failing to replace the solution regularly or allowing it to evaporate in the lens case....
http://www.nytimes.com/2006/05/15/business/15cnd-eye.html