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Bausch Lomb Renu Moistureloc Linked to Eye Infection Fusarium Keratitis
Contact Lens Solution Product Recall
In April 2006, eye care company Bausch & Lomb suspended sales of its ReNu with MoistureLoc contact lens solution after health officials linked the product to a serious fungal infection of the eye - fusarium keratitis. According to the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention, investigators are reviewing reports of 109 cases of suspected Fusarium keratitis in people in 17 states since June 2005. Although only 30 of those patients have been interviewed, 26 of the 28 who wore soft contact lenses reported using ReNu brand products. Eight patients had to undergo corneal transplants.
In February 2006, Bausch & Lomb stopped sale of ReNu in Hong Kong and Singapore because of an increase in the fungal infection. Over 30 million Americans wear soft contact lenses.
In May 2006, Bausch & Lomb announced that cases of Fusarium keratitis had been reported by ReNu users in Europe, the first time the company acknowledged European cases since the news of the fungus went public. The Centers for Disease Control and Prevention also stated that over a dozen people diagnosed with the fungus had used a different ReNu product, ReNu Multiplus, which the company is still selling. In at least six separate cases, according to the CDC, people used solutions from two other companies.
On May 15th, 2006, Bausch & Lomb announced that they would permanently withdraw ReNu with MoistureLoc , the new-formula contact-lens cleaner viewed as the "potential root cause" of a far-flung outbreak of fungal eye infections known to cause blindness. The Food and Drug Administration has reported that the eye-care company thinks ReNu with MoistureLoc's unique disinfecting and moisturizing agents "in certain unusual circumstances can increase the risk" of developing Fusarium keratitis.
If you have suffered an eye injury while using the Baush and Lomb products, you may have a claim. Contact our experienced ReNu Recall Attorneys, or fill out our ReNu Recall Case Evaluation form. ReNu with MoistureLoc Recall
The Centers for Disease Control and Prevention on May 9, 2006 said it has confirmed 106 cases of serious eye infection that may be linked to contact lens use. The number of confirmed Fusarium keratitis cases has grown by four since Friday, when the CDC last reported data.
The CDC said that throughout the investigation, the proportion of patients who reported using Bausch & Lomb Inc.'s ReNu with MoistureLoc has remained relatively consistent, at around 50% to 60% of confirmed cases. Of the 98 confirmed cases of which the CDC has complete data, 66% reported using ReNu with MoistureLoc, while 21% said they used Bausch & Lomb's ReNu MultiPlus product.
Eye-care products maker Bausch & Lomb Inc. halted U.S. sales of its ReNu with MoistureLoc solution on April 10 when the Centers for Disease Control and Prevention revealed it was investigating a flurry of Fusarium keratitis infections in Americans using the product.
The proportion of patients who said they used MoistureLoc has since held steady at around 50 percent to 60 percent of the 102 cases confirmed so far, the CDC said. Other patients have reported using other ReNu brands and six said they used cleaners made by Alcon Inc. and Advanced Medical Optics Inc., it said.
"At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak," the Atlanta-based agency said in a statement.
The agency has received a total of 195 reports of eye infections caused by Fusarium keratitis of which 12 are "possible cases" and 81 were still under investigation. On Tuesday, the CDC said it had received 191 reports, including 86 confirmed cases.
Fifty-six of the confirmed cases involved contact-lens wearers, with 32 of them saying they used MoistureLoc, 15 saying they used ReNu MultiPlus and seven an unspecified ReNu product. In some cases, patients reporting using more than one type of lens cleaner.
A federal inspection of a Bausch & Lomb factory in Greenville, S.C., where MoistureLoc is made has not turned up evidence of contamination, but extensive microbiological tests could take weeks to analyze.
Without eye-drop treatment, the infection can scar the cornea and blind its victims. At least eight patients have required cornea transplants. Because it's not a disease that doctors must report, it is unclear how many cases occur annually.
Of the more than 30 million Americans who wear contact lenses, about 2.3 million of them use MoistureLoc and nearly 11 million use MultiPlus.
MoistureLoc first hit store shelves in late 2004 and contains new-generation moisturizing and conditioning agents. It generated $45 million in U.S. sales last year.