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Storm mounts for B&L

This article was originally published in The Gray Sheet

Executive Summary

Centers for Disease Control & Prevention confirms 102 U.S. cases of the fungal eye infection Fusarium keratitis associated with contact lens use and potentially linked to Bausch & Lomb ReNu contact lens solutions, as of May 5. Adding 12 possible cases and 81 still under investigation brings the total to 195. CDC had reported 109 suspected cases as of April 9 (1"The Gray Sheet" April 17, 2006, p. 6). Of the 58 confirmed cases with complete data, 32 involved ReNu with MoistureLoc, which was withdrawn from the market last month as a precaution. However, 15 additional reports cite ReNu MultiPlus, seven relate to unspecified ReNu, and six reports cite competitors' products - including three for Alcon and three for Advanced Medical Optics products. Some cases included use of more than one solution and some of the cases might otherwise have occurred naturally, CDC notes. Reports of some additional infections have originated in Europe. FDA emphasizes that its interest in ReNu with MoistureLoc is based on the disproportionate number of potentially related infections relative to market share...

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