BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3392418 · Received October 7, 2013

    Report

    Report Number
    9614546-2013-00180
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    September 5, 2013
    Report Date
    September 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. BASED ON THE MANUFACTURING RECORD REVIEW AND HISTORICAL REVIEW NO DEVIATIONS WERE FOUND. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED AND EVALUATED BY OUR MANUFACTURING SITE WHERE A VISUAL INSPECTION SHOWED THE LENS WAS INTACT. THE LENS WAS IDENTIFIED AS A TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRAOCULAR LENS, MODEL ZMB00 DUE TO THE PRESENCE OF RINGS ON THE OPTIC SURFACE. THE LENS WAS RECEIVED HAVING BOTH HAPTICS OPENED. THE HAPTICS WERE SLIGHTLY BENT MOST LIKELY ATTRIBUTED TO THE EXPLANT PROCEDURE. THE LENS CONDITION IS CONSISTENT WITH A LENS THAT WAS EXPLANTED FROM THE PATIENT'S EYE. INVESTIGATION OF THE RETURN SAMPLE SHOWED NO NON-CONFORMANCES. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR HAD ISSUES WITH A TECNIS MULTIFOCAL ZMB00+25 DIOPTER INTRAOCULAR LENS (IOL). UPON INSERTING THE LENS INTO PATIENT'S EYES, THE HAPTICS DIDN¿T OPEN AND THE LENS STAYED CENTRALIZED. THE LENS WAS IMPLANTED, BUT THE HAPTICS NEVER OPENED. THE LENS WAS REMOVED AND REPLACED. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506173 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention