BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHACOFRAGMENTATION DEVICE - UNKNOWN MODEL

    MDR report key: 12138125 · Received July 7, 2021

    Report

    Report Number
    MW5102399
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 6, 2021
    Manufacturer
    UNK
    Product Code
    HQC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PHACOFRAGMENTATION OF MY LEFT EYE DURING CATARACT SURGERY RESULTED IN A POSTERIOR LENS CAPSULE RUPTURE AND VITREOUS PROLAPSE. THIS LED TO RETINAL DETACHMENT THAT REQUIRED URGENT SURGERY. CATARACT SURGERY WAS PERFORMED BY (B)(6) AT (B)(6) SURGERY CENTER AT (B)(6). MODEL OF PHACOFRAGMENTATION DEVICE (PROCODE HQC) WAS NOT PROVIDED TO ME, THE PATIENT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023046 PHACOFRAGMENTATION DEVICE - UNKNOWN MODEL UNIT, PHACOFRAGMENTATION HQC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention