FDA Issues Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu MoistureLoc® Contact Lens Solution

The Food and Drug Administration (FDA) says it is continuing to work closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu MoistureLoc® contact lens solution from the market until the agencies have had a chance to conclude their investigation.

The FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22, 2006, and will continue inspections of the Greenville, S.C. manufacturing plant and other facilities through next week. While the investigation continues, the FDA will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.

The FDA and CDC are advising consumers to take precautions to reduce their risk for Fusarium keratitis through preventive practices for contact lens wearers that include:

-- Wash hands with soap and water, and dry (lint-free method) before handling lenses.

-- Wear and replace lenses according to the schedule prescribed by the doctor.

-- Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.

-- Keep the contact lens case clean and replace every 3 to 6 months.

-- Remove the lenses and consult your doctor immediately if you experience symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling.

Source: FDA

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