-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, AROKCDgLS4kvG1pK5B5+5liY/YzOJjQzGSHBJ5gOcMPkcHbYUqc+1mprn2yBNr3f bKmL7IKqpHMQrwm2taulfQ== 0001104659-06-024811.txt : 20060413 0001104659-06-024811.hdr.sgml : 20060413 20060412205249 ACCESSION NUMBER: 0001104659-06-024811 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060410 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060413 DATE AS OF CHANGE: 20060412 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BAUSCH & LOMB INC CENTRAL INDEX KEY: 0000010427 STANDARD INDUSTRIAL CLASSIFICATION: OPHTHALMIC GOODS [3851] IRS NUMBER: 160345235 STATE OF INCORPORATION: NY FISCAL YEAR END: 1226 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-04105 FILM NUMBER: 06757161 BUSINESS ADDRESS: STREET 1: BAUSCH & LOMB INCORPORATED STREET 2: ONE BAUSCH & LOMB PLACE CITY: ROCHESTER STATE: NY ZIP: 14604-2701 BUSINESS PHONE: 5853386000 MAIL ADDRESS: STREET 1: ONE BAUSCH & LOMB PLACE STREET 2: P O BOX 54 CITY: ROCHESTER STATE: NY ZIP: 14604-2701 8-K 1 a06-8948_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  April 10, 2006

 


 

BAUSCH & LOMB INCORPORATED

(Exact name of registrant as specified in its charter)

 

New York

 

1-4105

 

16-0345235

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

One Bausch & Lomb Place, Rochester, NY

 

 

 

14604-2701

(Address of principal executive offices)

 

 

 

(Zip Code)

 

 

 

 

 

Registrant’s telephone number, including area code: (585) 338.6000

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

ITEM 8.01     OTHER EVENTS.

 

On April 10, 2006, the Company announced that it has temporarily suspended U.S. shipments of ReNu® with MoistureLoc® produced at its Greenville, S.C., manufacturing facility. This action does not affect any other Bausch & Lomb products. Details of the announcement appear in the Company’s April 10, 2006 press releases, copies of which are attached as Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 8-K.

 

On April 12, 2006, the Company held a conference call (the “Conference Call”) to provide investors with a general update about the current situation regarding U.S. shipments of ReNu® with MoistureLoc® solutions and about the status of the Company’s continuing collaboration with the U.S. Centers for Disease Control, the U.S. Food and Drug Administration and other health agencies investigating an increase in reports of fungal keratitis infections among contact lens wearers in the United States.

 

During the Conference Call, the Company also announced that it is unlikely to file its 2005 Annual Report on Form 10-K until after the expected filing date of April 30, 2006 that was previously announced in its Form 12b-25 filed March 17, 2006. This expected delay beyond April 30, 2006 is due to the Company’s ongoing efforts with respect to the matters described in the March 17, 2006 Form 12b-25 filing.

 

Below is information about accessing a rebroadcast of the Conference Call:

 

 

Available:

April 12, 2006 (1:30 p.m. ET) – April 16, 2006 (Midnight ET)

 

 

 

 

Telephone Number:

(719) 457-0820

 

 

 

 

Confirmation Code:

2047677

 

ITEM 9.01

 

FINANCIAL STATEMENTS AND EXHIBITS

 

 

 

(a)

 

Financial statements of businesses acquired.

 

 

   Not applicable

 

 

 

(b)

 

Pro forma financial information.

 

 

   Not applicable

 

 

 

(c)

 

Exhibits. The following exhibit is furnished as part of this report:

 

 

 

 

 

99.1                           Press Release dated April 10, 2006.

 

 

 

 

 

99.2                           Press Release dated April 10, 2006.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

BAUSCH & LOMB INCORPORATED

 

 

/s/ Stephen C. McCluski

 

Stephen C. McCluski

Senior Vice President and Chief Financial Officer

 

Date: April 12, 2006

 

3


EX-99.1 2 a06-8948_1ex99d1.htm EX-99

Exhibit 99.1

 

Bausch & Lomb Temporarily Suspends U.S. Shipments of ReNu® with MoistureLoc® Produced at Greenville, S.C., Manufacturing Facility Pending Investigation of Reports of Fusarium Infections Among Contact Lens Wearers

 

FOR RELEASE MONDAY, APRIL 10, 2006

 

Rochester, NY — Bausch & Lomb (NYSE:BOL) announced today that it is temporarily suspending U.S. shipments of ReNu® with MoistureLoc® produced at its Greenville, S.C., manufacturing facility in order to facilitate the further investigation of reports of fungal keratitis infections among contact lens wearers in the United States. This action does not affect any other Bausch & Lomb products. Today’s announcement follows the release of a report by the U.S. Centers for Disease Control and Prevention that it is reviewing reports of 109 cases of suspected fungal keratitis. The CDC reports that the majority of cases have yet to be reviewed, but of the 30 cases reviewed to date, 28 involved contact lens wearers. Twenty-one reported using ReNu brand contact lens care products and 5 reported using a combination of ReNu and products manufactured by other companies. Bausch & Lomb has been collaborating with the U.S. Food and Drug Administration, the CDC, major eye centers and health authorities in a comprehensive investigation to determine if the reports represent an increase in the historical incidence of these infections, and to determine the root cause.

 

“Bausch & Lomb’s first priority is the health and safety of consumers,” said Ronald L. Zarrella, chairman and CEO of the company. “The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S. manufactured ReNu with MoistureLoc in the underlying data. The source of these infections has not been determined. Based on our extensive testing, analysis and further internal reviews, and communications with leading experts, the available scientific evidence does not establish any type of ReNu solution as a cause.

 

“The CDC has not determined if these reports represent an increase of Fusarium keratitis infections and is continuing to investigate the association, if any, of these cases with any product. Nonetheless, in the interest of public health, we will voluntarily suspend U.S. shipments of ReNu with MoistureLoc while we pursue all appropriate steps to bring this investigation to a definitive conclusion,” Zarrella concluded.

 

Bausch & Lomb encourages contact lens wearers to follow these guidelines from the American Optometric Association:

 

                  Carefully and regularly clean contact lenses, as directed by an optometrist and the patient information included with lens care products.

                  Rub the contact lenses with fingers and rinse thoroughly before soaking the lenses overnight in enough multi-purpose solution to completely cover the lens.

                  Store lenses in the proper case and replace the lens storage case every three months. Clean the contact lens case after each use and keep the case open and dry between cleanings.

                  Use the proper products to clean and disinfect contact lenses as recommended by your optometrist. Remember that saline solutions and rewetting drops are not designed to disinfect lenses.

                  Only fresh solution should be used to clean and disinfect contact lenses. Never re-use old solution. Contact lens solution must be changed every day, even if the lenses are not used daily.

                  Always replace old contacts when you get a new contact prescription.

 

###

 



 

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 outcome of litigation; the outcome of Company and governmental investigations and reviews of events described in this news release and in the Company’s prior disclosures concerning those investigations; 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.

 

®/™ denote trademarks of Bausch & Lomb Incorporated.

 


EX-99.2 3 a06-8948_1ex99d2.htm EX-99

Exhibit 99.2

 

Bausch & Lomb Provides Information Regarding U.S. Sales of ReNu® with MoistureLoc® Solution

 

FOR RELEASE MONDAY, APRIL 10, 2006

 

Rochester, NY — Bausch & Lomb (NYSE:BOL) earlier today announced that it is temporarily suspending U.S. shipments of ReNu® with MoistureLoc® lens care solutions produced in its Greenville, S.C., manufacturing facility. In an effort to provide investors with assistance in understanding the magnitude of revenues derived from the ReNu with MoistureLoc solutions, the company indicated that the product generated sales of approximately $45 million in the United States in 2005.

 

###

 



 

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 outcome of litigation; the outcome of Company and governmental investigations and reviews of events described in this news release and in the Company’s prior disclosures concerning those investigations; 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.

 

®/™ denote trademarks of Bausch & Lomb Incorporated.

 


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