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Recent Activity Relating to ReNu with MoistureLoc

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On April 10, 2006 (updated: April 21, 2006), Daniel G. Schultz, M.D., Director Center for Devices and Radiological Health (part of the FDA), signed a Dear Healthcare Practitioner letter (Preliminary Public Health Notification-Fungal Keratitis Infections Related to Contact Lens Use, available at http://www.fda.gov/cdrh/safety/041006-keratitis.html). It provided updated information on the recent increase in reports of a rare but serious fungal infection of the eye in soft contact lens wearers in the United States. The letter noted that fungal keratitis caused by the Fusarium fungus may cause vision loss requiring corneal transplants.

Also, on April 10, 2006, the FDA published FDA News For Immediate Release, P06-56, Investigation of Serious Eye Infections Associated With Soft Contact Lens Use and Contact Lens Solution Consumers Are Advised to Follow Good Hygiene Practices and Manufacturers’ Instructions to Prevent Infection, available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01354.html. The FDA News underscored that this matter is related to an increasing number of reports of rare but serious fungal infections in the eye caused by a Fusarium fungus, and the 109 cases in 17 states are under investigation by CDC and public health authorities. The FDA also quoted Dr. Schultz, who stated that some of the patients had used other solutions in addition to the ReNu brand, and the source of this fungus has not yet been identified. It also specified the status of Bausch & Lomb’s withdrawal of the ReNu MoistureLoc products: “the manufacturer informed FDA that it was voluntarily stopping shipment of the product.” The FDA noted that Fusarium species are normally found in many plants, soil, and tap water. The annual risk of contact lens-related microbial keratitis is estimated in most studies to be between four and 21 per 10,000 patients, depending on whether the lenses are worn only during the day or continuously overnight.

On April 11, 2006, with an update on April 21st, MedWatch posted a new article on its Web site, Fungal Keratitis Infections Related to Contact Lens Use, available at http://www.fda.gov/medwatch/safety/2006/safety06.htm. The MedWatch article noted “the majority of the individuals (26) reported using Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection.” The MedWatch article referred to 5 separate documents from the FDA (4) and CDC (1).

On April 13, 2006, Bausch & Lomb published, An important message from Bausch & Lomb, available at www.bausch.com. It was signed by Ron Zarella, Chairman, Bausch & Lomb. The Message narrows the issues down to “one of our product, ReNu with MoistureLoc, manufactured at our United States plant.” The message also underlined that “[n]othing has yet been found to show that ReNu with MoistureLoc contributed to these infections in any way.” The document noted that three countries in Asia and the U.S. were “all served from the U.S. plant. In other markets-Europe, China and India, for example-the product is made in other factories, and there have been no unusual trends in Fusarium infections reported.”

On April 13, 2006, Bausch & Lomb released the News, Bausch & Lomb Asks Retailers to Remove U.S.-Manufactured ReNu with MoistureLoc from Shelves; and Recommends Consumers Switch to Another Solution Pending Investigation of Reports of Fusarium Infections Among Contact Lens Wearers. The Company’s News stated, “[this] action does not apply to other Bausch & Lomb products or to ReNu with MoistureLoc manufactured at factories outside the United States.”

On April 16, 2006, Bausch & Lomb took out a full-page ad in the Sunday New York Times (and many other newspapers) apologizing for the “situation” with its ReNu with MoistureLoc product and urging retailers to take the product of their shelves and consumers to discontinue using ReNu with MoistureLoc and switch to ReNu MultiPlus. The advertisement denies that its product is the cause, but does admit that the CDC has identified “a disproportionate association of a small number of events with ReNu with MoistureLoc manufactured in the [United States].”

On April 21, 2006, the FDA published, Contact Lenses and Eye Infections April 21, 2006, available at http://www.fda.gov/oc/opacom/hottopics/contacts.html. This document stated that both the FDA and CDC are continuing joint inspections of the Bausch & Lomb plant and facilities in Greenville, South Carolina including testing of products, environmental factors and raw materials. Because of the nature of the [fungus] (Fusarium), extensive microbiological testing is being conducted and may take up to one month to fully analyze.

On April 28, 2006, The American Academy of Ophthalmology published, Information on Fusarium (Fungal) Keratitis, Latest Numbers: 77 Confirmed Cases; 105 Under Investigation. The AAO stated that a total of 77 cases have now been confirmed of Fusarium keratitis…105 cases remain under investigation; 29 states or territories are now listed with a confirmed case or a case under investigation.

The number of confirmed cases of Fusarium keratitis in ReNu users continues to mount.