BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS IOL

    MDR report key: 6910633 · Received October 3, 2017

    Report

    Report Number
    6910633
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 12, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS INC.
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LENS WAS NOT FOLDED CORRECTLY AND DID NOT DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690892 TECNIS IOL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS INC. PCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR