BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMINAR

    MDR report key: 14854557 · Received June 29, 2022

    Report

    Report Number
    3012236936-2022-01673
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 29, 2022
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HQC
    UDI-DI
    05050474537200
    PMA / PMN Number
    K111882
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: OPOHF21L, 60334477 SLEEVE, ELLIPS FX HANDPIECE S/N UNKNOWN, VERITAS ADVANCED INFUSION PACK, LOT #60355024, MODEL #VRT-AI. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT TRENDING, AND RISK DOCUMENTATION FOR THIS DEVICE WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN DEBRIS WAS SEEN INSIDE THE PATIENT¿S OPERATIVE EYE. EVENT OCCURRED SHORTLY AFTER HE INSERTED THE PHACO TIP INTO THE EYE. A BRIEF DESCRIPTION OF THE EVENT INDICATED THAT THE DEBRIS WAS WHITE AND LOOKED LIKE WHITE STYROFOAM. IT WAS STATED THAT THE DEBRIS WAS ROUGHLY SPHERICAL IN SHAPE WITH A DIAMETER APPROXIMATELY 1MM (IT WAS SLIGHTLY LARGER THAN THE DIAMETER OF THE PHACO TIP WHICH WAS ONE OF OUR 21G TIPS). THE SURGEON WAS NOT ABLE TO ASPIRATE IT OUT JUST USING VACUUM SO HE APPLIED A LITTLE ULTRASOUND WHICH ALLOWED THE SYSTEM TO ASPIRATE MOST OF IT, BUT HE NOTICED THE ULTRASOUND CAUSED TWO VERY SMALL PIECES TO BREAK FREE AND IMBED THEMSELVES IN THE IRIS. THE SURGEON WAS UNABLE TO REMOVE THE DEBRIS. THE TIP IS NOT AVAILABLE FOR RETURN. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE LAMINAR TIP. A SEPARATE REPORT IS BEING SUBMITTED FOR THE ELLIPS HANDPIECE UNDER 3012236936-2022-01726.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253439 LAMINAR UNIT, PHACOFRAGMENTATION HQC JOHNSON & JOHNSON SURGICAL VISION, INC. OPOCR3021L 5205447 05050474537200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown