BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARIS 23GA POSTERIOR PACK W AFI & WF

    MDR report key: 3062930 · Received April 12, 2013

    Report

    Report Number
    1920664-2013-00057
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS DISCARDED THE DEVICE. A SUPPLEMENTAL MDR REPORT WILL BE FILED SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE FOR INVESTIGATION. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN INCIDENT WHICH INVOLVED A PT WHERE THE CUTTER BECAME STUCK IN THE CLOSED POSITION, AND CAUSED A RETINAL TEAR THAT REQUIRED SECONDARY LASER TREATMENT. ALSO, THE EYE WENT VERY SOFT TO THE POINT OF COLLAPSE BECAUSE THE INFUSION WAS NOT WORKING PROPERLY. TO OUR KNOWLEDGE, THE PT WAS TREATED AND IS BEING FOLLOWED. THE FACILITY DISCARDED PACK AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157835 STELLARIS 23GA POSTERIOR PACK W AFI & WF HQC BAUSCH & LOMB, INC. BL5423W U8731

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS PC, S/N (B)(4)