BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3955067 · Received July 24, 2014

    Report

    Report Number
    9614546-2014-00185
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 29, 2025
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. THE LENS WAS CUT IN PIECES, MOST LIKELY TO FACILITATE THE EXPLANT PROCESS. UNDER 12X MAGNIFICATION, 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 OPTIC IS DAMAGED AND SCRATCHES ARE PRESENT. 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. BOTH HAPTICS HAVE A DENT. THE TYPE OF DENT IS POTENTIALLY CONSISTENT WITH THE IMPRINT OF FORCEPS. THE TYPE OF DAMAGE DOES NOT SUGGEST OR SUPPORT THE DENTS WERE INTRODUCED DURING MANUFACTURING. THE CONDITION OF THE RETURNED LENS PRECLUDED OTHER TESTING METHODS, SUCH AS DIOPTER VERIFICATION, DIMENSIONAL, AND FUNCTIONAL TESTING. MANUFACTURING RECORDS WERE REVIEWED. DEVICE HISTORY RECORDS WERE REVIEWED AND THE PRODUCTION ORDER WAS RELEASED WITHOUT ANY NON-CONFORMANCES. THERE WAS ONE DEVIATION NOTED THAT WAS NOT RELATED TO THIS COMPLAINT. 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 A ZMA 13.5 DIOPTER INTRAOCULAR LENS (IOL) WOULD NOT STAY CENTERED. IT WAS IMPLANTED ON (B)(6) 2014. ONE DAY POST OP (B)(6) 2014 THE LENS WAS NOTED TO BE DE-CENTERED. IT WAS REPOSITIONED ON (B)(6) 2014. ON (B)(6) 2014 IT WAS DECENTERED. ON (B)(6) 2014 IT WAS EXPLANTED BY A RETINAL SPECIALIST. THE CAPSULE TORE AND A VITRECTOMY WAS PERFORMED. THE SURGEON USED SUTURES TO STABILIZE THE LENS THAT WAS SUBSEQUENTLY IMPLANTED. THE SUTURES IRRITATED THE PATIENT'S CORNEA AND ''CAUSED ISSUES''. IN FOLLOW UP, THE REPORTER INDICATED THE PATIENT IS SLOWLY IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434051 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention