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May 15, 2006 Bausch &
Lomb to Permanently Remove ReNu MoistureLoc Dear Eye Care Professional: I want to personally update you on our MoistureLoc investigation. After an extensive investigation involving thousands of tests, millions of dollars and collaboration with government agencies, health authorities and independent experts, there is no evidence of product contamination, tampering, counterfeiting or sterility failure. That led us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances. We are continuing to investigate this link, but in the meantime, we're taking the most responsible action in the interests of our customers by discontinuing the MoistureLoc formula. TV and newspaper ads will begin Tuesday, May 16th with a message from our Chairman Ron Zarrella to consumers announcing our decision to cease distribution of MoistureLoc worldwide. You can preview the TV spot and print ad at www.bausch.com. The FDA supports
our decision to permanently remove MoistureLoc from the market.
Additionally in the FDA's press release dated May 15, 2006, they stated
"To date, data available do not indicate a problem with ReNu MultiPlus The FDA's team of inspectors has been in the Greenville plant for nearly two months, and has indicated that the inspection is being finalized. Because we've been working alongside them throughout the process, we expect they will give us a series of detailed observations. We've already addressed some of the issues they will cite and are in the process of addressing the rest. All of the aspects of their investigation have been taken into consideration in the decision we announced this morning. For us, the important thing -- as Dr. Daniel Schultz, Director of the Center for Devices and Radiological Health of the U.S. FDA said in a media briefing today, is that -- based upon the information available to date - there appears to be no link between the findings at the plant and the Fusarium outbreak. Recommend ReNu MultiPlus with Confidence This extensive investigation confirmed our confidence in our other ReNu formulas. Our ReNu MultiPlus formula continues to provide unsurpassed cleaning and disinfecting properties that have made it the leading multipurpose formula for the past 9 years. We will be providing MultiPlus care kits to Eye Care Professionals beginning in June of this year and will launch our consumer and trade campaigns in support of this line immediately. You can continue to recommend ReNu MultiPlus with confidence to your patient base. We also would like
to invite you to join us in helping your patients to better follow your
contact lens recommendations. As part of a larger initiative,
we have launched the Bausch & Lomb Wear&Care We thank you for your continued support during this investigation and look forward to focusing our efforts behind our proven MultiPlus formula. Your Bausch & Lomb representative will be presenting you with further details concerning our MultiPlus support programs. Sincerely,![]() Robert J. Moore General Manager -- U.S. Vision Care |
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