BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS ZCBOO 22.0 DIOPTER

    MDR report key: 5846162 · Received August 4, 2016

    Report

    Report Number
    5846162
    Event Type
    Malfunction
    Date Received
    August 4, 2016
    Date of Event
    May 10, 2016
    Report Date
    August 3, 2016
    Manufacturer
    ABBOTT MEDICAL OPTICS INC. (AMO)
    Product Code
    MFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE CATARACT EXTRACTION, THE PC IOL (TECNIS ZCBOO 22.0 DIOPTER, SERIAL NUMBER (B)(4), EXPIRATION DATE 2/25/2020) WAS OPENED ONTO THE STERILE FIELD. THE SURGEON NOTED THAT THE CAPSULAR BAG THAT NORMALLY HOLDS THE INTRAOCULAR LENS WAS TORN AND WOULD NOT SUPPORT THIS LENS. ANOTHER LENS WAS OPENED AND INSERTED INTO THE SULCUS SPACE WITHOUT INCIDENT- THE OPERATING ROOM NURSE INDICATED THAT SHE RETURNED THE LENS TO THE COMPANY FOR CREDIT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497800 TECNIS ZCBOO 22.0 DIOPTER LENS, MULTIFOCAL INTRAOCULAR MFK ABBOTT MEDICAL OPTICS INC. (AMO)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO