RENU WITH MOISTURELOC

by Heidi Turner

The US Food and Drug Administration (FDA) has announced that it is considering stricter labeling standards for contact lens solutions such as Bausch & Lomb's ReNu with MoistureLoc. The announcement comes after two massive recalls of contact lens solutions because the solutions were linked to serious eye infections.

ReNu with MoistureLoc was linked to an outbreak of Fusarium keratitis, an eye infection that can potentially lead to blindness. The outbreak led to ReNu with MoistureLoc being recalled on April 13, 2006. According to the FDA, approximately one-third of patients who developed the Fusarium keratitis infection required corneal transplants.

Bausch & Lomb has come under fire for not reporting all cases of the eye infection that were linked to ReNu with MoistureLoc. The company was also cited for violations at its Greenville, South Carolina manufacturing plant.

Dr. Elmer Tu, Associate Professor of Clinical Ophthalmology at the University of Illinois at Chicago, told the panel that there was a strong association between the use of ReNu with MoistureLoc and Fusarium infections. "There was broad agreement between studies in Singapore, Hong Kong and with the CDC demonstrating a strong association here in the United States," Tu said. He also noted that there was a steep drop in the number of Fusarium cases once ReNu with MoistureLoc was recalled.

Tu recommended that lens solutions be tested under "real-world conditions," that even minor changes in formulation be subject to strict testing and that "discard by" dates should be included in the labeling of lens care products.

Experts at the hearing noted that so-called improvements to contact lens solutions may have actually increased the risk of Fusarium keratitis infection. Dr. Joseph C. Hutter, chemical engineer reviewer in the Division of Ophthalmic and ENT Devices, noted that ReNu with MoistureLoc included a polymer that was designed to help retain moisture on the contact lens. However, studies showed that the polymer film actually interfered with the disinfection of the Fusarium fungus.

Patients who were affected by Fusarium keratitis reported serious side effects including permanent vision loss and corneal ulcers. Symptoms of the infection include blurred vision, light sensitivity, redness, discharge from the eyes and headaches. Many patients are now investigating lawsuits against Bausch & Lomb, alleging that ReNu with MoistureLoc was unreasonably dangerous and defective. Plaintiffs also claim that the company did not properly warn consumers about the risks associated with the contact lens solution.

Furthermore, they allege that Bausch & Lomb was negligent in failing to remove the product from the market and continuing to market and sell the product.

If you or someone you love was harmed by the use of ReNu with MoistureLoc, you may be eligible to join a lawsuit against Bausch & Lomb. Such a lawsuit could help to recover costs associated with the Fusarium keratitis infection, including medical expenses.

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