BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS MICRO INCISION VACUUM PACK

    MDR report key: 3161789 · Received June 6, 2013

    Report

    Report Number
    1920664-2013-00138
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE STERILIZATION AND LOT HISTORY RECORDS COULD NOT BE REVIEWED. REPORT 3 OF 3. SEE 1920664-2013-00136 AND 1920664-2013-00137.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE SURGEON WAS USING THE MICS NEEDLE FOR THE FIRST TIME WHEN THE POSTERIOR CAPSULE WAS RUPTURED. IT WAS NOTED THERE WAS A BURR ON THE TIP AND SIDE OF THE TIP OF THE NEEDLE. THEY OPENED A NEW NEEDLE TO COMPLETE THE SURGERY. THE PT REQUIRED A VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251671 STELLARIS MICRO INCISION VACUUM PACK HQC BAUSCH & LOMB, INC. BL5113 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention