BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL

    MDR report key: 3911981 · Received May 29, 2014

    Report

    Report Number
    3911981
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, WHILE FOLDING THE LENS, WE NOTICED THAT THE TIP OF THE CARTRIDGE WAS BROKEN. A NEW CARTRIDGE WAS OPENED. THE BROKEN CARTRIDGE NEVER CONTACTED THE PATIENT.======================MANUFACTURER RESPONSE FOR IOL CARTRIDGE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================TRACK AND TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316258 TECNIS 1-PIECE IOL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS INC. (AMO) NONE *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR