BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNIS 1

    MDR report key: 7276174 · Received February 15, 2018

    Report

    Report Number
    MW5075313
    Event Type
    Injury
    Date Received
    February 15, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 14, 2018
    Manufacturer
    AMO PUERTO RICO MANUFACTURING INC.
    Product Code
    MJP
    UDI-DI
    2482261712
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE PT'S LENS WAS INJECTED AND AS THE LENS BEGAN TO UNFOLD, IT WAS NOTICED THAT THE TRAILING HAPTIC WAS SEVERED. THE SURGEON THEN REMOVED THE DAMAGED LENS AND IMPLANTED A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117399 TECHNIS 1 INTRAOCULAR LENS MJP AMO PUERTO RICO MANUFACTURING INC. PCB00 PCB0000220 2482261712

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention