AOSEPT PLUS/CLEAR CARE PLUS WITH HYDRAGLYDE CLEANING AND DISINFECTING SOLUTION

Description of Event or Problem

AS INITIALLY REPORTED BY A NON-HEALTHCARE PROFESSIONAL, STATING THAT THE CONSUMER NOTICED, RAINBOW HALOS AROUND LIGHTS. THE CONSUMER ASSUMED THIS INDICATED THAT THE LENSES WERE EXCEPTIONALLY CLEAN AND CONTINUED TO WEAR THEM FOR APPROXIMATELY EIGHT HOURS BEFORE REMOVING THEM. THE FOLLOWING MORNING, THE CONSUMER AWOKE WITH SEVERE SYMPTOMS AFFECTING BOTH EYES. BOTH EYES WERE SIGNIFICANTLY SWOLLEN AND INFLAMED, AND THE CONSUMER EXPERIENCED EXCRUCIATING PAIN, WAS UNABLE TO TOLERATE OPENING THE EYES, AND HAD SEVERELY IMPAIRED VISION. THE CONSUMER WAS TAKEN TO THE EMERGENCY DEPARTMENT, WHERE MEDICATED EYE DROPS WERE PRESCRIBED, AND FOLLOW-UP WITH AN OPTOMETRIST WAS RECOMMENDED. DURING THE OPTOMETRY EVALUATION, THE CONSUMER WAS DIAGNOSED WITH BILATERAL CHEMICAL BURNS OF THE CORNEAS AND OCULAR TOXICITY. THE OPTOMETRIST EXPLAINED THAT THE BURNS HAD STRIPPED THE PROTECTIVE SURFACE OF BOTH CORNEAS. THE INJURIES WERE IDENTICAL IN BOTH EYES AND CORRESPONDED TO THE SHAPE OF THE CONTACT LENSES, SUGGESTING THAT THE CHEMICAL EXPOSURE OCCURRED THROUGH THE LENSES. THE OPTOMETRIST FURTHER ADVISED THAT THE CONTACT LENS SOLUTION LIKELY FAILED TO NEUTRALIZE DESPITE THE LENSES REMAINING IN THE NEUTRALIZING CASE FOR APPROXIMATELY FOURTY EIGHT HOURS AND EXPRESSED CONCERN THAT THE NEUTRALIZING DISC MAY NOT BE FUNCTIONING CONSISTENTLY AS INTENDED. AS A RESULT OF THE INJURIES, THE CONSUMER EXPERIENCED BLURRED VISION, DOUBLE VISION, SIGNIFICANT PAIN, EXTREME LIGHT SENSITIVITY AND REQUIRED ONGOING MEDICAL TREATMENT, PRESCRIPTION MEDICATIONS, AND MULTIPLE FOLLOW-UP APPOINTMENTS. NO OTHER CHANGES TO THE CONSUMER'S CONTACT LENS ROUTINE WERE REPORTED. AT THE TIME OF THIS REPORT, THE CURRENT CONDITION OF CONSUMER¿S EYE WAS SYMPTOMS CONTINUING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

Additional Manufacturer Narrative

H.3., H.6.: THE COMPLAINT SAMPLE HAS NOT RETURNED FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).