BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION PHACO HANDPIECE

    MDR report key: 9291124 · Received November 6, 2019

    Report

    Report Number
    MW5090945
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 28, 2019
    Report Date
    November 5, 2019
    Manufacturer
    UNK
    Product Code
    HQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CATARACT EXTRACTION SURGERY, UPON INITIATION OF PHACO EMULSIFICATION, A SMALL WHITE PELLET APPROX 3MM IN SIZE, WAS DISCHARGED INTO THE EYE FROM THE PHACO HAND PIECE. THE HAND PIECE WAS REMOVED AND THE WHITE PELLET WAS ASPIRATED OUT OF THE EYE. ALCON RESEARCH, LLC. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078440 CENTURION PHACO HANDPIECE UNIT PHACOFRAGMENTATION HQC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention