BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 4123601 · Received September 26, 2014

    Report

    Report Number
    9614546-2014-00227
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THE LENS WAS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWS THE LENS CAN BE IDENTIFIED AS TECNIS MULTIFOCAL ACRYLIC 3-PIECE INTRA OCULAR LENS BECAUSE OF THE TYPE OF HAPTICS AND THE PRESENCE OF A DIFFRACTIVE RING PATTERN ON THE OPTIC. THE LENS IS CONTAMINATED, DUST PARTICLES ARE PRESENT. THIS IS EXPECTED AS THE LENS WAS TRANSPORTED FROM CONTROLLED ENVIRONMENT DURING MANUFACTURING TO A NON-STERILE, NON-ENVIRONMENTAL CONTROLLED AREA. CONSIDERING THE CONDITION OF THE LENS, ADDITIONAL ANALYSIS IS NOT POSSIBLE. MANUFACTURING RECORDS WERE REVIEWED. DEVICE HISTORY RECORDS SHOW THAT THE PRODUCT ORDER WAS PRODUCED WITH NO NON-CONFORMANCES OR DEVIATIONS. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES AND NO NON-CONFORMING MATERIALS REPORTS. THE IN-LINE OPTICAL INSPECTION DATA SHOWS THE LENS IS WITHIN POWER SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN ZMA00U0215 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AFTER SHE COULD NOT ADJUST TO MULTIFOCALITY. THE REPORT INDICATED SHE EXPERIENCED ''REFRACTIVE NAUSEA''.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600015 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention