BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 3180679 · Received June 20, 2013

    Report

    Report Number
    2648035-2013-00253
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    January 9, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT OF INTRAOCULAR LENS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A MEDWATCH FORM ((B)(4)) THAT INDICATES THAT AN INTRAOCULAR LENS EVENT DATE WAS (B)(6) 2013 REPORTING MODEL ZCB00 (23.0 DIOPTER). IT WAS STATED IN THE EVENT DESCRIPTION THAT THE LENS WAS NOTED TO HAVE A SMALL DEFECT (NOT FURTHER SPECIFIED) SO IT WAS EXPLANTED AND REPLACED WITH AN IDENTICAL SIZE, ZCB00 23.0 DIOPTER. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280586 TECNIS 1-PIECE MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention