BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    53GA POSTERIOR PROCEDURAL PACK W/INTEGRATED VENT

    MDR report key: 7844281 · Received September 4, 2018

    Report

    Report Number
    0001920664-2018-00114
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Date of Event
    August 3, 2018
    Report Date
    August 6, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORT #1 OF 3 (0001920664-2018-00115 AND 0001920664-2018-00116). REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS HAVE BEEN SUBMITTED AGAINST LOT W1330. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT W1330 WAS MANUFACTURED IN MARCH 2018. PER CAPA 610815 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, INCLUDING BL5523W. THE FIRST LOT OF BL5523W THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2091 IN JUN 2018. ANY BL5523W PRODUCT WITH LOT NO. W2091 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    (REPORT #1 OF 3). WE WERE INFORMED THAT THE DEVICE USED DURING THE REPORTED EVENT WAS DISPOSED AT THE FACILITY AND IT IS NOT AVAILABLE FOR EVALUATION. MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM A USER FACILITY IN THE (B)(6) STATED THAT THREE DIFFERENT CUTTERS WERE NOT CUTTING THE VITREOUS ON THREE DIFFERENT PATIENTS AND NEEDED TO BE CHANGED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683757 53GA POSTERIOR PROCEDURAL PACK W/INTEGRATED VENT UNIT, PHACOFRAGMENTATION. HQC BAUSCH + LOMB BL5523W W1330

    Patients

    Seq Age Sex Outcome Treatment
    1