BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSPORT DELIVERY SYSTEM

    MDR report key: 37752 · Received September 5, 1996

    Report

    Report Number
    2027189-1996-00004
    Event Type
    Injury
    Date Received
    September 5, 1996
    Date of Event
    July 30, 1996
    Report Date
    September 5, 1996
    Manufacturer
    CHIRON VISION CORP.
    Product Code
    KYB
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A4: PATIENT WEIGHT NOT PROVIDED BY USER FACILITY. D7: NA - DEVICE IS NOT AN IMPLANT. D8: NA - DEVICE IS NOT AN IMPLANT, THEREFORE IT CANNOT BE EXPLANTED. F9: INFORMATION UNK BECAUSE USER FACILITY WAS UNABLE TO PROVIDE LOT NUMBER OF THE DEVICE. F10: PATIENT CODE - (CORRECTED) 2200 (OTHER) INCISION ENLARGEMENT, UNLABELED. H3: EVALUATION RESULTS - RETURNED PRODUCT CONFIRMED THAT A PIECE OF THE LENS REMAINED STUCK IN THE INSERTION DEVICE. EVALUATION OF THE RETURNED LENS SHOWED THAT A CORNER OF THE HAPTIC WAS TORN AWAY.

    Description of Event or Problem · 1

    THE LENS WAS INSERTED INTO THE EYE AND WAS OBSERVED TO HAVE A PIECE MISSING FROM ONE OF THE HAPTICS. THE INCISION WAS ENLARGED TO REMOVE THE LENS. USER FACILITY STATES THAT NO PORTIONS OF THE LENS WERE LEFT IN THE PT'S EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT DELIVERY SYSTEM LENS, GUIDE, INTRAOCULAR KYB CHIRON VISION CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR AMVISC VISCOELASTIC C10UB INTRAOCULAR LENS.