BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3130720 · Received May 24, 2013

    Report

    Report Number
    2648035-2013-00234
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    BASED ON THE MANUFACTURING RECORD REVIEW AND HISTORICAL REVIEW, NO DEVIATIONS WERE FOUND DURING THE INVESTIGATION. MFR REPORT # SHOULD HAVE BEEN (B)(4). USAGE OF DEVICE: INITIAL. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THAT THE RETURNED SAMPLE WAS COVERED WITH CONTAMINATIONS, NO OPTICAL DEVIATIONS ON THE OPTIC COULD BE FOUND. ONE OF THE HAPTICS WAS DISTORTED. DIOPTER VERIFICATION COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE RETURNED LENS.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT A INTRAOCULAR LENS (IOL) WAS EXPLANTED AFTER THE PATIENT EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. INCISION ENLARGEMENT WAS NOT REQUIRED AND THE DOCTOR REPLACED THE OLD IOL WITH A NEW IOL WITH THE SAME MODEL. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232620 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention