FDA Formally Endorses Market Withdrawal of Bausch & Lomb ReNu MoistureLoc
Posted by
Robert WolfApril 24, 2006 9:40 AMThe Food and Drug Administration (FDA) issued a formal press release on April 14 indicating that this agency is working closely with the Centers for Disease Control and Prevention (CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections. The FDA stated that it "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 is continuing inspections of the Greenville, SC manufacturing plant and other facilities through the end of April. While the investigation continues, the FDA states that it will work with CDC to identify and confirm cases of Fusarium keratitis reported by state health departments and from FDA Medwatch reports.
Many users of the ReNu MoistureLoc contact lens solution have complained about infections which have developed whie using the product. These infections have allegedly led to varying degrees of significant injuries.
While the investigation is going, both 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:
1. Wash hands with soap and water, and dry (lint-free method) before handling lenses.
2. Wear and replace lenses according to the schedule prescribed by the doctor.
3. Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer.
4. Keep the contact lens case clean and replace every 3-6 months.
5. 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.
For more information from the FDA, individuals can visit the FDA's Contact Lens and Eye Infections website