BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1-PIECE IOL

    MDR report key: 3911972 · Received May 29, 2014

    Report

    Report Number
    3911972
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 22, 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

    WHILE PERFORMING CATARACT SURGERY, THE LENS WAS FOLDED AND STAFF NOTED THAT THE CARTRIDGE WAS CRACKED. WE HAVE HAD FOUR INCIDENTS INVOVLING CRACKED CARTRIDGES. NO INJURY TO 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
    316257 TECNIS 1-PIECE IOL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS, INC (AMO) NONE NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR