Contact Lens Recall
Written by Faith Anderson on October 17, 2011
Recalled CooperVision Contact Lenses
According to the FDA notice, CooperVision Avaira Toric soft contact lenses are used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had the natural lens of their eye removed and who have not had previous eye diseases with lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The Avaira Soft Contact Lens is indicated for single-use disposable wear and daily wear, the FDA informs consumers. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.
Reported Injuries Associated with Recalled Lenses
This FDA notice comes after the agency demanded that the Fairport, NY firm broaden its notification of the recall of Avaira Toric lenses manufactured from November 1, 2010 to August 3, 2011. The FDA now reports that approximately 778,301 lenses are affected by this recall, a significantly higher estimate than CooperVision’s original, which included about 600,000 lenses. FDA officials have so far received at least fifteen reports of injuries related to the recalled contact lenses, including severe injuries such as corneal tears, according to an FDA spokesperson.
FDA Recommendation for Consumers
According to the FDA, consumers should return their lenses to their eye care practitioner if they have the affected contact lenses. For consumers who have worn Avaira Toric contact lenses and experienced any symptoms, the FDA recommends that they stop wearing the lenses immediately and contact their eye care practitioner for further advice. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these recalled products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. According to an FDA spokesperson, “The FDA will continue to monitor this recall’s effectiveness to ensure that the affected devices are moved from the marketplace and not used by consumers.”