BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTI-FREE REPLENISH MPDS

    MDR report key: 880902 · Received July 13, 2007

    Report

    Report Number
    1610287-2007-00023
    Event Type
    Injury
    Date Received
    July 13, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ALCON LABORATORIES INC.,/FORT WORTH
    Product Code
    LPN
    PMA / PMN Number
    K050729
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION. EVALUATION OF RETENTION SAMPLE IN PROGRESS. BATCH RECORD REVIEW IN PROGRESS. NO SIMILAR REPORTS ON LOT 120690F. ADDITIONAL INFORMATION WAS REQUESTED FROM THE OPTOMETRIST: 06/19/2007, 07/09/2007, 07/10/2007 NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    OPTOMETRIST REPORTED EXAMINING A PATIENT WHO HAD SPOTS ON HER CORNEA AFTER USING THIS PRODUCT FOR A WEEK AND A HALF. SHE REFERRED THE PATIENT TO ANOTHER FACILITY, WHERE A PHYSICIAN DIAGNOSED "CORNEAL BURNS". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-FREE REPLENISH MPDS LENS CARE DISINFECTING SOLUTIONS LPN ALCON LABORATORIES INC.,/FORT WORTH NA 120690F

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other