BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNFOLDER PLATINUM SERIES CARTRIDGE

    MDR report key: 4820747 · Received May 27, 2015

    Report

    Report Number
    4820747
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 27, 2015
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER MANIPULATION OF LENS, IT WAS NOTED THAT A SMALL PIECE OF THE ABBOTT CARTRIDGE HAD BROKEN OFF; PHYSICIAN IMMEDIATELY RETRIEVED IT AND NOTIFIED US. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343515 UNFOLDER PLATINUM SERIES CARTRIDGE LENS, GUIDE, INTRAOCULAR KYB ABBOTT MEDICAL OPTICS INC. (AMO) * CA00855

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR