Bausch & Lomb Voluntarily Recalls ReNu
May 15, 2006 17:18

Bausch & Lomb is permanently removing its ReNu MoistureLoc® contact lens solution from worldwide markets

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Bausch & Lomb Pulls ReNu With Moisturloc Lens-Solution
May 15, 2006 17:33

Date: 5/15/2006
Reason: Rare fungal infections that can cause blindness.
Distribution: Worldwide

Extensive federal inspections of its factory in Greenville, S.C., where MoistureLoc was made for U.S. and several Asian markets, have not turned up evidence of "contamination, tampering, counterfeiting or sterility failure," Ron Zarrella, the eye-care product maker's chief executive, said in a statement. "That leads us to conclude that some aspect of the MoistureLoc formula may be increasing the relative risk of Fusarium infection in unusual circumstances," he said.

FDA STATEMENT on ReNu
May 15, 2006 17:38

Media Inquiries: Kristen Neese May 15, 2006 301-827-6242 Consumer Inquiries: 888-INFO-FDA

Bausch & Lomb Global Recall of ReNu with MoistureLoc Contact Lens Cleaning Solution On Thursday, May 11, 2006 a team from Bausch & Lomb met with Food & Drug Administration (FDA) officials to share information resulting from the company's internal investigation into cases of Fusarium keratitis associated with ReNu with MoistureLoc. Bausch & Lomb has proposed that unique characteristics of the formulation of the ReNu with MoistureLoc product in certain unusual circumstances can increase the risk of Fusarium infection.

Based on this scientific and epidemiological data suggesting that ReNu with MoistureLoc may increase susceptibility to Fusarium, Bausch & Lomb has decided to permanently remove the ReNu with MoistureLoc product worldwide. FDA supports this decision. To date, data available do not indicate a problem with ReNu MultiPlus or ReNu Multi-Purpose or generic brands of this contact lens cleaning solution. While FDA is still concluding its scientific evaluations and expects additional information to be submitted by the sponsor, at this time we recognize that Bausch & Lomb has proposed the formulation as the potential root cause of the increased relative risk of Fusarium keratitis associated with use of the ReNu with MoistureLoc product.

FDA will continue to review cultures and epidemiological data and if there is new information that adds to or changes our current understanding, we will act on it in a timely and appropriate manner. As part of the joint Center for Disease Control & Prevention (CDC) and FDA investigation, field officers have been inspecting the Bausch & Lomb plant and facilities in Greenville, SC since March 22, 2006. While the plant inspection is being finalized, there is still some additional testing to be completed. The agency plans to issue observations from the inspections imminently.

ReNu with MoistureLoc contact lens solution, manufactured in the Greenville, SC plant, was voluntarily withdrawn from the market in the United States on April 13, 2006. To date, a majority of the confirmed Fusarium cases have been associated with the ReNu with MoistureLoc. Our interest in the MoistureLoc product has been based on the disproportionate number of cases of Fusarium keratitis associated with ReNu with Moisture Loc compared to the overall product market share. Based on

CDC reports, the number of cases involving various contact lens solutions other than MoistureLoc has remained consistent throughout our investigation, and not disproportionate from the routine incidence of this infection in the population. ####

FDA Says Bausch Delayed Reports Of Eye Infections
May 17, 2006 17:19

"Bausch & Lomb Inc. delayed for weeks telling regulators about reports linking its contact-lens solution to cases of a rare eye infection, according to a Food and Drug Administration inspection report. The FDA report, released on the agency's Web site, also identified more than a dozen potential manufacturing violations at the Greenville, S.C., plant that makes the product, called ReNu with MoistureLoc. On Monday, Bausch announced a world-wide recall of the lens solution and acknowledged it may increase the risk of serious eye infections. The FDA report terms the manufacturing problems 'objectionable conditions' but said the review doesn't represent a final agency determination regarding compliance. In a statement, the FDA said preliminary results from testing done at the plant haven't uncovered a link between the formulation of the lens-solution product and the eye infections. The agency said it is continuing to investigate the matter."

David Armstrong, Wall Street Journal, 5/17/06

Bausch & Lomb Clarifies Reporting Of Fusarium Keratitis Cases to FDA
May 17, 2006 17:42

Wednesday, May 17, 2006 ROCHESTER, N.Y. -

Bausch & Lomb wishes to clarify information contained in media reports about the U.S. Food and Drug Administration's inspection of Bausch & Lomb's manufacturing plant and distribution facility in Greenville, S.C., that erroneously suggest that Bausch & Lomb withheld from FDA information the Company received about Fusarium infections in Singapore.

The media reports followed FDA's release yesterday of its inspection's preliminary observations, one of which noted that the Company "failed to notify the Agency of 35 serious injury reports of Fusarium keratitis from Singapore's Minister of Health in February 2006 relating to ReNu® MoistureLoc Multipurpose Solution."

Within days of receiving a report in February of an unusual spike of Fusarium keratitis cases among contact lens wearers in Singapore, Bausch & Lomb discussed those initial case reports with FDA's Office of Compliance in the Center for Devices and Radiological Health. As details of the Singapore cases were gathered, the Company continued to provide updates to FDA. On April 5, Company representatives met in person with agency representatives to provide a full briefing on its Fusarium investigation activities. After receiving guidance from FDA on its preferences for the content and form of the formal report, Bausch & Lomb filed the Medical Device Report on April 7.

FDA's preliminary observations also noted that unspecified "keratitis complaints" reported to the Company in July 2005 were not reported to the agency.
Those six reports of noninfectious keratitis, or general eye inflammation, among contact lens wearers were not related to Fusarium infections and did not require medical treatment. Bausch & Lomb followed guidelines developed for use by all contact lens and lens-care product manufacturers that were adopted by the Contact Lens Institute in 1997 and provided to FDA. These guidelines were developed by the industry association to assist its members in complying with FDA medical device reporting requirements. Under these guidelines, noninfectious eye inflammations not requiring medical treatment to preclude permanent damage or impairment are not considered to be reportable. The Company will be working with the agency to assess whether these guidelines should continue to be referenced in future reporting decisions. Bausch & Lomb continues to work closely with FDA to address all issues in its preliminary report of the Greenville plant inspection and remains committed to maintaining its operations in compliance with all regulatory requirements and good manufacturing practices. This news release contains, among other things, certain statements of a forward-looking nature relating to future events or the future business performance of Bausch & Lomb. Such statements involve a number of risks and uncertainties including, without limitation, those concerning global and local economic, political and sociological conditions; currency exchange rates; government pricing changes and initiatives with respect to healthcare products; changes in laws and regulations relating to the Company's products and the import and export of such products; product development and rationalization; enrollment and completion of clinical trials; the ability of the Company to obtain regulatory approvals; the impact of the matters described in this news release on sales of the Company's other lens care products or other products, the cost to the Company of recalling product, defending matters in litigation, investigations and future product testing and other related costs and expenses; the outcome of the Audit Committee's continuing independent investigations of events described in the Company's prior disclosures concerning those investigations; the outcome of PriceWaterhouseCoopers' quarterly review process in connection with the filing of the Company's Quarterly Report on Form 10-Q for the third quarter of fiscal 2005 and of the extended year-end review process in connection with the filing of the Company's Annual Report on Form 10-K for fiscal 2005 and the expected, estimated adjustments described in this news release; the filing of the Company's 10-Q for third quarter of fiscal 2005 and its 10-K for fiscal 2005; the possibility that the market for the sale of certain products and services may not develop as expected; the financial well-being of key customers, development partners and suppliers; the successful execution of marketing strategies; continued efforts in managing and reducing costs and expenses; the successful completion and integration of business acquisitions; the Company's success in introducing and implementing its enterprise-wide information technology initiatives, including the corresponding impact on internal controls and reporting; the Company's success in the process of management testing, including evaluation of results; continued positive relations with third party financing sources and the risk factors listed from time to time in the Company's SEC filings, including but not limited to the Current Report on Form 8-K, dated June 14, 2002 and the Form 10-Q for the quarter ended June 25, 2005.

Bausch & Lomb is the eye health company, dedicated to perfecting vision and enhancing life for consumers around the world. Its core businesses include soft and rigid gas permeable contact lenses and lens care products, and ophthalmic surgical and pharmaceutical products. The Bausch & Lomb name is one of the best known and most respected healthcare brands in the world. Founded in 1853, the Company is headquartered in Rochester, New York. Bausch & Lomb's 2004 revenues were $2.2 billion; it employs approximately 13,700 people worldwide and its products are available in more than 100 countries. More information about the Company is on the Bausch & Lomb Web site at www.bausch.com. Copyright Bausch & Lomb Incorporated.