BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 4032455 · Received August 25, 2014

    Report

    Report Number
    2648035-2014-00413
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 31, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETURNED SAMPLE WAS INSPECTED AT THE MANUFACTURING SITE UNDER 10X MICROSCOPE MAGNIFICATION. THE LENS WAS RECEIVED CUT INTO TWO (2) PIECES, WITH A SMALL AMOUNT MISSING FROM ONE OF THE PIECES. A RED STAIN WAS OBSERVED ON THE LENS, STAIN APPEARS TO BE BLOOD. ALSO NEAR THE STAIN, SCRATCHES WERE OBSERVED. VISUAL INSPECTION REVEALED SURFACE RESIDUALS (DEBRIS/PARTICLES) ON THE SAMPLE, WHICH IS CONSISTENT WITH THE LENS BEING HANDLED OUT OF A STERILE ENVIRONMENT. MIQ (MEASURING IMAGE QUALITY) TEST PERFORMED SHOWED LENS CORRESPONDS TO A 29.0 DIOPTER LENS. DUE TO THE RETURNED CONDITION OF THE SAMPLE, NO FURTHER INVESTIGATION WAS PERFORMED. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD WERE IN COMPLIANCE WITH MANUFACTURING SPECIFICATIONS. ALL TEST RESULTS SHOWED A PASS CONDITION. A REVIEW OF THE MANUFACTURING PROCESS AND/OR MATERIALS SHOW THERE WERE NO CHANGES IN MANUFACTURING METHOD, INSPECTIONS OR SPECIFICATIONS ASSOCIATED WITH THIS PRODUCTION ORDER. PRODUCT MET MANUFACTURING CRITERIA PRIOR TO RELEASE. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE, DUE TO DYSPHOTOPSIA CAUSING IMPAIRED VISION AND VISIBILITY. NO INCISION ENLARGEMENT OCCURRED AND NO VITRECTOMY WAS PERFORMED. A REPLACEMENT LENS WAS PLACED. REPLACEMENT LENS WAS OF THE SAME MODEL (ZMA00) DIOPTER 25.5 (SERIAL NUMBER (B)(4)). PATIENT IS REPORTED TO BE FINE, POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513623 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention