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B&L Responds: ReNu FDA Letter 11.06

in this section: FDA ReNu Recall | FDA: Failure to Report, 11.06 | B&L Responds: ReNu FDA Letter 11.06 | FDA Warning | Litigation Proliferates, 10.07 | FDA Supports Withdrawal | FDA Public Health Notice | B&L Sales Fall | Bausch & Lomb Press Release | MultiPlus Recall, 3/07 | ReNu lawsuit


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Bausch & Lomb Responds to FDA Warning Letter on ReNu

Weitz & Luxenberg is no longer accepting ReNu with MoistureLoc cases.

Bausch & Lomb Receives FDA Warning Letter on ReNu related to Inspection at Greenville, S.C. Solutions Manufacturing Plant conducted in March-May 2006

FOR RELEASE MONDAY, NOVEMBER 6, 2006

ROCHESTER, N.Y. – Bausch & Lomb (NYSE: BOL) today announced that it has received a Warning Letter from the United States Food and Drug Administration relating to an inspection the agency conducted at the Company’s Greenville, S.C. solutions manufacturing plant during the period March 22 through May 15, 2006 in connection with reports of Fusarium keratitis from some users of ReNu with MoistureLoc solution produced in the facility. Although the inspection did not identify any conditions at the manufacturing facility that contributed to or caused the reported adverse events, it identified some important issues that the Company is addressing through a series of corrective actions. The Warning Letter contains no new observations, but rather documents those corrective actions still in process. Bausch & Lomb voluntarily initiated a global recall of its ReNu with MoistureLoc lens care solution on May 15, 2006.

In response to the FDA’s report on the inspection observations (FDA Form 483), the Company immediately initiated a series of corrective actions and submitted a comprehensive plan summarizing those actions on June 30, 2006. The Warning Letter summarizes the agency’s assessment of the corrective actions completed as of the Company’s June 30, 2006 response. Since that time, the Company has continued to keep the FDA updated on its progress toward completing the corrective actions outlined in its response to the Form 483.

At an update with agency representatives in mid-August, the Company reported having completed more than half of the action items. In a report submitted on October 12, which the agency has yet to finish reviewing, the Company reported that more than two-thirds of the action items had been completed; that the majority of the outstanding items were in the process of implementation according to schedule; and that a handful had been assigned new completion dates. Of the unfinished actions itemized in the Warning Letter, the great majority were reported as complete in the October 12 update, although, of course, they cannot be considered closed until the FDA has had the opportunity to review or inspect them.

Bausch & Lomb said today that it has taken very seriously its responsibility to respond with appropriate speed and thoroughness to the FDA’s observations. The Company has confidence in the products it manufactures at the facility based on the processes and systems in place. Bausch & Lomb is committed to completing the remainder of the action items in its corrective plan according to schedule, and expects to be ready for a re-inspection in the first quarter of 2007.

### 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 those concerning economic conditions, currency exchange rates, product development and introduction, the financial well-being of key customers, the successful execution of marketing strategies, the continued successful implementation of its efforts in managing and reducing costs and expenses, as well as the risk factors listed from time to time in the Company’s SEC filings, including but not limited to filings on Form 8-K and on Form 12b-25, each dated August 8, 2006.

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.

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If you have developed an severe eye infection resulting in vision loss after using ReNu contact lens solution, you may have a lawsuit claim against the manufacturer, Bausch & Lomb. To inquire about your possible ReNu lawsuit, fill out the form below for a free case evaluation. We will be in touch shortly.


Weitz & Luxenberg is no longer accepting ReNu with MoistureLoc cases.


see also:

FDA Public Health Notice ReNu MoistureLoc Attorney - FDA Public Health Notice
FDA ReNu Advisory: Fungal Eye Infection causes vision loss, blindness

FDA ReNu Recall FDA ReNu Recall - How does the ReNu Recall Affect You?
ReNu Recall - Bausch & Lomb Removes MoisureLoc from Shelves

News & Warnings ReNu Lawsuit - Bausch & Lomb’s Contact Lens Solution News & Warnings
Keep up to date with ReNu Brand contact lens solution News & Warnings

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