BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED

    MDR report key: 7901903 · Received September 24, 2018

    Report

    Report Number
    0001920664-2018-00129
    Event Type
    Malfunction
    Date Received
    September 24, 2018
    Date of Event
    August 22, 2018
    Report Date
    August 22, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: CHANGED TO BL5323WV. ADDITIONAL INFO: THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE ACCEPTABLE. THERE IS A CORRECTIVE AND PREVENTATIVE ACTION (CAPA 610815) OPENED FOR THIS TYPE OF COMPLAINT. THE VITRECTOMY TUBESET USED ON THE STELLARIS PC PACKS AND STANDALONE POUCHED VITRECTOMY CUTTERS WAS REPLACED WITH A NEW VITRECTOMY TUBESET. THE NEW VITRECTOMY TUBESET PROVIDES A GREATER OPERATING RANGE BETWEEN THE PRESSURE REQUIRED TO CLOSE THE VITRECTOMY CUTTER INNER NEEDLE AND THE PRESSURE REQUIRED TO OPEN THE VITRECTOMY CUTTER INNER NEEDLE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED A VITRECTOMY CUTTER HAD SUCTION BUT NO CUTTING ACTION. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744082 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5323WV W0819

    Patients

    Seq Age Sex Outcome Treatment
    1