BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1 PIECE IOL

    MDR report key: 3912005 · Received May 29, 2014

    Report

    Report Number
    3912005
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 14, 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 INTRAOCULAR LENS THE DOCTOR NOTICED THAT THE TIP OF CARTRIDGE WAS CRACKED. THEY REMOVED THE CRACKED FROM OPERATIVE FILED AND OPENED A NEW CARTRIDGE AND PROCEEDED. THE CRACKED CARTRIDGE NEVER CAME IN CONTACT WITH PATIENT.======================MANUFACTURER RESPONSE FOR IOL CARTRIDGE, ABBOTT - AMO (PER SITE REPORTER).======================TRACK AND TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316786 TECNIS 1 PIECE IOL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS, INC. (AMO) * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR