BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL

    MDR report key: 3911976 · Received May 29, 2014

    Report

    Report Number
    3911976
    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

    THE PRODCUT IS A CARTRIDGE USED TO INSERT A CATARACT LENS. WHILE INSERTING THE LENS INTO THE PATIENT, A CRACK SOUND WAS HEARD. PHYSICIAN STOPPED AND REMOVED THE INSERTED LENS, A NEW INSERTER WAS USED THE LENS WAS IMPLANTED. NO HARM TO PATIENT. EYE WAS CHECKED UNDER THE MICROSCOPE FOR ANY BROKEN PIECES OF CARTRIDGE. EYE WAS CLEAR AND THE CARTRIDGE WAS INTACT EXCEPT FOR CRACK THAT COULD BE SEEN MICROSCOPICALLY.======================MANUFACTURER RESPONSE FOR IOL CARTRIDGE, ABBOTT - AMO (PER SITE REPORTER).======================TRACK AND TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316259 TECNIS 1-PIECE IOL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS, INC. (AMO) NONE *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR