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Bausch & Lomb Fusarium Keratitis Problem Spans Globe

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The Singapore’s Ministry of Health (“MOH”) has also been active in investigating claims of Fusarium keratitis resulting from the use of Bausch & Lomb’s ReNu with MoistureLoc. As of February 20, 2006, the MOH had found 39 cases that tested positive for Fusarium, and each person had a history of contact lens use. Out of the 39 cases, 34 said that they had used ReNu.

The majority of the 39 cases (92%) started developing infection in the second half of 2005 or later. On April 12, 2006, the Singapore Ministry of Health published, Update on Contact Lens Related Fungal Corneal Infections. The Update reports that between for the period November 1, 2004 and April 12, 2006, 75 cases of fungal corneal infection have been reported, each of which tested positive for Fusarium with a history of contact lens use. This compares with only two reported cases between January 1, 2004 to 31 October 31, 2004. Id.

A comprehensive case-control study (comparing contact lens users with infection and contact lens users without corneal infection) was undertaken in or about February/March 2006 to investigate risk factors for the spike in fungal corneal infection. Id. The study found a strong association between corneal infection and the use of ReNu solution. Id. The association remained strong even after taking into consideration socio-demographic, lens, hygiene and environmental factors. Id. Singapore’s Ministry of Health focused its tests not only on possible contamination of the product in question from the particular United States (South Carolina) plant, but also on the efficacy of disinfectants used. It is believed that the focus on the disinfectant may uncover the problems with the product.