BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTI-FREE REPLENISH MULTI-PURPOSE DISINFECTING SOLUTION

    MDR report key: 990442 · Received November 16, 2007

    Report

    Report Number
    1610287-2007-00056
    Event Type
    Other
    Date Received
    November 16, 2007
    Date of Event
    July 24, 2007
    Report Date
    October 24, 2007
    Manufacturer
    ALCON - FT WORTH, ALCON LABORATORIES, INC
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN REC'D FOR EVAL. EVAL OF RETENTION SAMPLE FROM LOT 120688F AND BATCH RECORD REVIEW ARE IN PROGRESS. NO SIMILAR REPORTS FOR LOT 120688F.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE AND HER SON EXPERIENCED "EXTREME REDNESS, BURNING, WEEPING EYES, LIMITED DISCHARGE, HEADACHES, AND CHANGE IN VISION" WHILE USING THIS PROD FOR A PERIOD OF SIX MONTHS. SHE STATED THE SYMPTOMS RESOLVED WHEN CONTACT LENS WEAR AND PROD USE WERE DISCONTINUED AND REAPPEARED WHEN THEY RESUMED CONTACT LENS WEAR AND PROD USE. THE CONSUMER INDICATED SHE AND HER SON WEAR DIFFERENT BRANDS OF CONTACT LENSES (UNSPECIFIED). CONSUMER ID INFO WAS NOT RELEASED. TWO MEDWATCH REPORTS FOR THIS REPORT: 1610287-2007-55 AND1610287-2007-56.

    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 - FT WORTH, ALCON LABORATORIES, INC NA 120688F

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other CONTACT LENSES (UNK BRAND AND DATES)