15.05.2006 13:00:00
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Bausch & Lomb Voluntarily Recalls MoistureLoc(R) Worldwide; Customer Safety is Our Top Priority, Says CEO
"Bausch & Lomb's top priority is the safety of our customers, andwe want them to have complete confidence in our products." said Bausch& Lomb Chairman and CEO Ronald L. Zarrella.
Health authorities in Hong Kong, Singapore and the United Statespreviously reported that the MoistureLoc formula was used by many ofthe contact lens wearers treated for a rare eye infection calledFusarium keratitis. Bausch & Lomb immediately launched a massiveinvestigation to determine the root cause of the infections andunderstand why there appeared to be a disproportionate associationwith MoistureLoc. Because the product sold in those markets was madein the company's Greenville, S.C. factory, Bausch & Lomb initiallyremoved the MoistureLoc product from markets supplied by that plant.
"After an extensive investigation involving thousands of tests,millions of dollars and collaboration with government agencies, healthauthorities and independent experts, there is no evidence of productcontamination, tampering, counterfeiting or sterility failure,"Zarrella said. "That leads us to conclude that some aspect of theMoistureLoc formula may be increasing the relative risk of Fusariuminfection in unusual circumstances. We are continuing to investigatethis link, but in the meantime, we're taking the most responsibleaction in the interests of our customers by discontinuing theMoistureLoc formula. We are taking this action even in countries wherewe have seen no unusual trends in Fusarium infections, for example inChina and the markets in Europe, the Middle East, and Africa."
The FDA and the U.S. Centers for Disease Control and Preventionpreviously reported that MoistureLoc solution was disproportionatelyrepresented among the confirmed cases of Fusarium keratitis, ascompared with other Bausch & Lomb or competitive products.
Bausch & Lomb suggests that former MoistureLoc users switch toReNu MultiPlus or ReNu Multi-Purpose, the brands more people worldwidehave chosen for their contact lens care. Those products each havelongstanding unsurpassed records of safety and effectiveness, and eachhas a formula different from that of MoistureLoc. Manufacturing plantsin Greenville, S.C.; Milan, Italy; Beijing, China; and Bhiwadi, India,will shift production from MoistureLoc to the ReNu MultiPlus and ReNuMulti-Purpose formulas.
Bausch & Lomb is working with eye care practitioners to launch newprograms that will provide consumers with products and information forbetter eye health. Eye care practitioners agree that contact lenswearers reduce the risk of infection when they follow proper lens wearand care practices.
Bausch & Lomb introduced the MoistureLoc formula in late 2004. Theproduct contributed approximately $100 million of sales in 2005. Thecompany has not provided revenue or earnings guidance for 2006 and hasnot estimated the financial impact of this action on its 2006 results.
INVESTOR CALL: Bausch & Lomb will hold a conference call for
investors today at 2:00 p.m. Eastern. The call-in number is
913.981.5591. The rebroadcast number: 719.457.0820, confirmation
6465434. Replay will be available from 5:30 p.m. ET through midnight
May 19, 2006. The investor call will be broadcast live on the
Internet, available on the Investor Relations page of the Company's
Web site, www.bausch.com, or at www.vcall.com.
NOTE TO TELEVISION PRODUCERS: Satellite feeds of a videotape
statement from Bausch & Lomb Chairman and CEO Ron Zarrella will be
available as follows:
UNITED STATES - THREE FEEDS: Airdate: Today, Monday May 15, 2006
At 11:00 a.m. to 11:15 a.m. ET; 1:00 p.m. to 1:15 p.m. ET; 3:00 p.m.
to 3:15 p.m. ET Satellite Coordinates: IA 6 Transponder 21 C-Band
Downlink Frequency: 4120 V
ASIA FEED: Airdate: Tuesday, May 16, 2006
Time: 0545-0600 GMT
Title: Bausch & Lomb Feed to Asia
Satellite: PAS-2/08C MCPC CH.2 (169' E)
Downlink Frequency: D/L: 3901.000 MHz Horizontal
FEC: 3/4
Symbol Rate (Ms/s) 30.80000
Virtual Channel: 2, Network ID: 1
Color: NTSC
PAS Ref: 05162006-375 (see below)
Playout: Pacific Television Center +1.310.287.3800
Uplink: Pas +1.404-381-2320
EUROPE FEED Airdate: Tuesday, May 16, 2006
Time: 1100-1115 GMT
Title: Bausch & Lomb Feed to Europe
Satellite: AB1/B1/CH E (9MHZ)
Downlink Frequency: 10966.17H
FEC: 3/4
Symbol Rate: 6.1113
This news release contains, among other things, certain statementsof a forward-looking nature relating to future events or the futurebusiness performance of Bausch & Lomb. Such statements involve anumber of risks and uncertainties including, without limitation, thoseconcerning global and local economic, political and sociologicalconditions; currency exchange rates; government pricing changes andinitiatives with respect to healthcare products; changes in laws andregulations relating to the Company's products and the import andexport of such products; product development and rationalization;enrollment and completion of clinical trials; the ability of theCompany to obtain regulatory approvals; the impact of the mattersdescribed in this news release on sales of the Company's other lenscare products or other products, the cost to the Company of recallingproduct, defending matters in litigation, investigations and futureproduct testing and other related costs and expenses; the outcome ofthe Audit Committee's continuing independent investigations of eventsdescribed in the Company's prior disclosures concerning thoseinvestigations; the outcome of PriceWaterhouseCoopers' quarterlyreview process in connection with the filing of the Company'sQuarterly Report on Form 10-Q for the third quarter of fiscal 2005 andof the extended year-end review process in connection with the filingof the Company's Annual Report on Form 10-K for fiscal 2005 and theexpected, estimated adjustments described in this news release; thefiling of the Company's 10-Q for third quarter of fiscal 2005 and its10-K for fiscal 2005; the possibility that the market for the sale ofcertain products and services may not develop as expected; thefinancial well-being of key customers, development partners andsuppliers; the successful execution of marketing strategies; continuedefforts in managing and reducing costs and expenses; the successfulcompletion and integration of business acquisitions; the Company'ssuccess in introducing and implementing its enterprise-wideinformation technology initiatives, including the corresponding impacton internal controls and reporting; the Company's success in theprocess of management testing, including evaluation of results;continued positive relations with third party financing sources andthe risk factors listed from time to time in the Company's SECfilings, 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 perfectingvision and enhancing life for consumers around the world. Its corebusinesses include soft and rigid gas permeable contact lenses andlens care products, and ophthalmic surgical and pharmaceuticalproducts. The Bausch & Lomb name is one of the best known and mostrespected healthcare brands in the world. Founded in 1853, the Companyis headquartered in Rochester, New York. Bausch & Lomb's 2004 revenueswere $2.2 billion; it employs approximately 13,700 people worldwideand its products are available in more than 100 countries. Moreinformation about the Company is on the Bausch & Lomb Web site atwww.bausch.com. Copyright Bausch & Lomb Incorporated.
(R)/(TM) denote trademarks of Bausch & Lomb Incorporated.
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