BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH

    MDR report key: 1101749 · Received August 7, 2008

    Report

    Report Number
    1610287-2008-00025
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    ALCON - FORT WORTH / ACLON LABORATORIES, INC.
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. PRODUCT IS EXPIRED. BATCH RECORDS WERE REVIEWED FOR LOT 118759F AND NO DEVIATIONS WERE IDENTIFIED. THE CHEMISTRY AND MICROBIOLOGY TEST RESULTS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. TWO SIMILAR REPORTS FOR LOT 118759F HAVE BEEN RECEIVED. ADDITIONAL INFORMATION WAS REQUESTED ON 07/08/2008, 07/18/2008, 07/24/2008, AND 07/31/2008 AND RECEIVED ON 07/31/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTS EXPERIENCING A BURNING SENSATION, SWELLING, IRRITATION, PAIN, AND DECREASED VISION IN BOTH EYES (LEFT EYE LESS THAN RIGHT EYE) WITH USE OF AN EXPIRED BOTTLE OF THIS PRODUCT. SHE STATES THAT HER CONTACT LENSES BONDED TO HER EYES AND HER OPHTHALMOLOGIST PULLED THEM OFF WITH AN INSTRUMENT, FLUSHED HER EYES, AND TREATED HER WITH OCULAR ANTIBIOTICS. SHE REPORTS HER SYMPTOMS HAVE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. SHE PROVIDED A COPY OF HER MEDICAL RECORDS FROM THE OPHTHALMOLOGIST'S OFFICE, WHICH STATE THAT THE OPHTHALMOLOGIST DIAGNOSED HER WITH A "CHEMICAL BURN" ON HER RIGHT EYE. OPHTHALMOLOGIST'S NOTES ALSO STATE THAT THE SYMPTOMS HAVE RESOLVED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH LENS CARE DISINFECTING SOLUTIONS LPN ALCON - FORT WORTH / ACLON LABORATORIES, INC. NA 118759F

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other ACUVUE OASYS