BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 914199 · Received September 14, 2007

    Report

    Report Number
    1610287-2007-00039
    Event Type
    Injury
    Date Received
    September 14, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 16, 2007
    Manufacturer
    ALCON LABORATORIES, INC
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS BEEN RETURNED AND IS UNDERGOING TESTING. BATCH RECORD REVIEW IS IN PROGRESS. NO SIMILAR REPORTS FOR LOT 113455F. ADDITIONAL INFORMATION WAS REQUESTED FROM REPORTER (OD): 08/16/2007 AND 08/21/2007. REPORTER PROVIDED INFORMATION 08/16/2007 AND 09/05/2007. ADDITIONAL INFORMATION WAS REQUESTED FROM CONSUMER: 08/16/2007 AND 09/10/2007. CONSUMER PROVIDED INFORMATION 09/10/2007.

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT EXPERIENCED "CHEMICAL KERATITIS" IN BOTH EYES (OU) AFTER USING THIS BOTTLE OF PRODUCT. HE STATED IT CLEARLY LOOKED LIKE A "CHEMICAL BURN". HE INDICATED THE PATIENT TOLD HIM SHE HAD PREVIOUSLY USED PRODUCT FOR A LONG PERIOD OF TIME WITHOUT DIFFICULTY. UPON EXAMINATION IN 2007, THE OPTOMETRIST OBSERVED PITTED CORNEAS, RED EYES AND THE PATIENT INDICATED SHE WAS UNCOMFORTABLE, BUT NOT IN PAIN. HE TREATED HER WITH ARTIFICIAL TEARS AND AN ANTIBIOTIC/STEROID MEDICATION. THE PATIENT DISCONTINUED CONTACT LENS WEAR AND PRODUCT USE. THE OPTOMETRIST INDICATED THE PATIENT'S VISUAL ACUITY (VA) WAS 20/40 AND 20/60 (EYES NOT SPECIFIED) AT THIS VISIT. AT HER LAST VISIT FOUR DAYS LATER, HER VA HAD WORSENED TO 20/60 AND 20/100. THE OPTOMETRIST HAD NOT SEEN THE PATIENT PRIOR TO THE INITIAL VISIT AND HE WAS UNAWARE OF HER PREVIOUS VA. THE OPTOMETRIST RECOMMENDED THE PATIENT VISIT AN OPHTHALMOLOGIST, WHO UPON EXAMINATION CONFIRMED THE DIAGNOSIS OF CHEMICAL KERATITIS AND BOTH DOCTORS AGREED IT WAS NOT INFECTIOUS KERATITIS. THE OPTOMETRIST STATED THE PATIENT WEARS ACUVUE ADVANCE CONTACT LENSES FOR ASTIGMATISM. LENSES WERE TWO WEEKS OLD AT THE TIME OF THE INITIAL EXAMINATION. THE PATIENT REPORTED ON 09/10/2007 THAT HER EYES ARE BETTER AND HER VISION IS SLOWLY IMPROVING. THE OPHTHALMOLOGIST SHE WAS REFERRED TO BY THE OPTOMETRIST TOLD HER TO DISCONTINUE THE ANTIBIOTIC/STEROID MEDICATION AND TO ONLY USE SALINE DROPS TO HYDRATE HER CORNEAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION LENS CARE DISINFECTING SOLUTIONS LPN ALCON LABORATORIES, INC NA 113455F

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention ACUVUE ADVANCE CONTACT LENSES