BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3892859 · Received June 24, 2014

    Report

    Report Number
    9614546-2014-00165
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 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 AVAILABLE FOR EVALUATION: YES. RETURNED TO MANUFACTURER ON: 06/30/2014. THE LENS WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. VISUAL INSPECTION SHOWS THE RETURNED LENS IS CUT IN PIECES. VISUAL INSPECTION UNDER 12X MAGNIFICATION SHOWED THE LENS CAN BE IDENTIFIED AS TECNIS MULTIFOCAL ACRYLIC 3-PIECE INTRAOCULAR LENS. THE LENS IS CUT IN PIECES AND THE OPTIC IS DAMAGED. THE LENS IS CONTAMINATED, DUST PARTICLES ARE PRESENT. THIS IS EXPECTED AS THE LENS WAS EXPLANTED AND TRANSPORTED. VISUAL INSPECTION OF THE RETURNED LENS SHOWS THE LENS IS CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED. DEVICE HISTORY RECORDS (DHR) SHOWS THAT THE STERILIZATION BATCH WAS RELEASED; THERE WERE NO NON CONFORMANCES. THERE WERE NO ASSOCIATED NONCONFORMITY MATERIAL REPORTS WITH RESPECT TO THE PRODUCTION ORDER. THERE WERE NO ENVIRONMENTAL MONITORING RELATED NON CONFORMANCES. THE PRODUCT WAS NOT PRODUCED UNDER DEVIATION. THERE WERE NO PROCESS AND/OR MATERIAL CHANGES. BASED ON THE MANUFACTURING RECORD REVIEW AND HISTORICAL REVIEW NO NON CONFORMANCES WERE IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS 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

    WE RECEIVED A REPORT THAT AN ZMA 22.50 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AFTER SHE EXPERIENCED DYSPHOTOPSIA. THE GLARE WAS CONSIDERED A DISABILITY AND HER VISUAL ACUITY WAS 20/50. THE ORIGINAL INCISION WAS NOT ENLARGED AND THERE WERE NO COMPLICATIONS. PATIENT IS REPORTED TO HAVE RECOVERED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368557 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention