BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPS FX PHACO HANDPIECE

    MDR report key: 14854434 · Received June 29, 2022

    Report

    Report Number
    3012236936-2022-01726
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 29, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    PMA / PMN Number
    K060366
    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. IT WAS INDICATED THAT THE ELLIPS FX HANDPIECE HAD BEEN SITTING ON THE SHELF IN A PEEL PACK FOR APPROXIMATELY ONE YEAR BASED ON THE DATED STERILIZATION LABEL. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE ELLIPS FX HANDPIECE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE LAMINAR TIP UNDER 3012236936-2022-01673.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154483 ELLIPS FX PHACO HANDPIECE UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC 690880

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VERITAS CONSOLE S/N VERITAS, 202110049