BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE

    MDR report key: 14699533 · Received June 15, 2022

    Report

    Report Number
    0001932402-2022-00003
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 3, 2022
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQB
    UDI-DI
    20841305107094
    PMA / PMN Number
    K954306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THIS INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE NEEDLE QUALITY IS 100% CHECKED ON SITE BEFORE SHIPPING. ALSO, THE 55.70.25P DOES NOT COME WITH A CANNULA OR TROCAR. THE TROCAR ID MIGHT HAVE CONTRIBUTED TO THIS FAILURE. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    THE SALES REP ON SITE FOR SURGERY REPORTED THE LASER PROBE PULLED THE TROCAR OUT OF THE PATIENTS EYE. THE SURGERY WAS DELAYED MAYBE 10 MINUTES AND A SUTURE WAS REQUIRED TO CLOSE THE WOUND. NO ADDITIONAL ANESTHESIA REQUIRED. THEY WERE ABLE TO COMPLETE THE SURGERY WITH NO ADDITIONAL PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807867 25GA FLEXIBLE TAPERED ILLUMINATED LASER PROBE OPHTHALMIC LASER SYSTEM BEAM GUIDE HQB BAUSCH + LOMB 55.70.25P 222 20841305107094

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STELLARIS UNIT AND DISPOSABLE PACK.