BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3840792 · Received May 30, 2014

    Report

    Report Number
    9614546-2014-00147
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED THE IOL IS 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 TORIC ACRYLIC 1-PIECE INTRA OCULAR LENS BECAUSE OF THE PRESENCE OF MARKING HOLES. 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 THE PRODUCTION ORDER WAS MANUFACTURED WITHOUT ANY NON-CONFORMANCES OR DEVIATIONS. THERE WERE NOT PROCESS AND/OR MATERIAL CHANGES AND DIOPTER VERIFICATION RECORDS WERE WITHIN SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN ZCT400 TORIC INTRAOCULAR LENS WAS EXPLANTED AFTER THE PATIENT EXPERIENCED BLURRY VISION. A ZCT225 WAS IMPLANTED DURING THE SAME PROCEDURE. THE REPORT INDICATED THAT NEITHER AN INCISION ENLARGEMENT OR VITRECTOMY WERE REQUIRED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317872 TECNIS TORIC IOLS HQL ABBOTT MEDICAL OPTICS ZCT400

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention