BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 GA HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 7784118 · Received August 15, 2018

    Report

    Report Number
    0001920664-2018-00097
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 23, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    20757770057928
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFER TO CAPA (B)(4). CAPA (B)(4) WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT V8936 WAS MANUFACTURED IN MARCH 2017. PER CAPA (B)(4) AND QCR (B)(4) 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. THE VITRECTOMY TUBESET ENHANCEMENT WAS IMPLEMENTED ON THE IMPACTED PC PACKS AND POUCHED ACCESSORIES. THE FIRST LOT OF BL5625 THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2161 IN JULY 2018. ANY BL5625 PRODUCT WITH LOT NO. W2161 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT. REPORT 1 OF 2 SEE 1920664-2018-00098.

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE PRODUCT COMPLAINT CANNOT BE CONFIRMED, THERE WAS NO PRODUCT RETURNED FOR EVALUATION. FURTHER INVESTIGATION UNDERWAY. REPORT 1 OF 2 SEE 1920664-2018-00098.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTERS WOULD NOT CUT WHILE ASPIRATION CONTINUED. THE CUTTER WAS REPLACED WITH ANOTHER, AND THE SURGERY WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628561 25 GA HIGH SPEED VITRECTOMY CUTTER UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5625 V8936 20757770057928

    Patients

    Seq Age Sex Outcome Treatment
    1