BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2150035 · Received July 5, 2011

    Report

    Report Number
    9614546-2011-00050
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    August 23, 2010
    Report Date
    June 6, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040/S029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE LENS WAS NOT RECEIVED FOR ANALYSIS. THE LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE INFORMATION RECEIVED FROM THE SURGEON WE DO NOT SUSPECT THE LENS MALFUNCTIONED NOR CAUSED THIS ADVERSE EVENT. ALL INFORMATION CURRENTLY AVAILABLE IS PROVIDED IN THIS REPORT. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS(IOL) WAS RECEIVED AND INSPECTED UNDER ILLUMINATED 10X MAGNIFICATION. RESULTS SHOW A CUT OPTIC AND A BROKEN HAPTIC. NO MANUFACTURING DEFICIENCIES WERE OBSERVED. LENS MET ALL SPECIFICATIONS PRIOR TO RELEASE. OUR INVESTIGATION SUGGESTS THIS EVENT IS RELATED TO THE PATIENT'S EYE PATHOLOGY AND NOT TO THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR A MONOFOCAL IOL DUE TO THE PATIENT'S EPIRETINAL MEMBRANE, A PATHOLOGIC CONDITION OF THE EYE CAUSING VISUAL DISTORTION. RETINAL SPECIALIST RECOMMENDED THE EXCHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention