BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3844927 · Received June 3, 2014

    Report

    Report Number
    9614546-2014-00149
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    February 28, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EXPLANT OF AN INTRAOCULAR LENS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL EXAMINATION REVEALED THAT THE LENS WAS RECEIVED CUT IN PIECES, MOST PROBABLY TO MAKE EXPLANT POSSIBLE. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWED THE LENS IDENTIFIED AS TECNIS MULTIFOCAL ACRYLIC 1-PIECE INTRAOCULAR LENS BECAUSE OF THE PRESENCE OF A DIFFRACTIVE RING PATTERN ON THE OPTIC. THE LENS WAS CUT IN PIECES AND THE OPTIC WAS DAMAGED. THE LENS WAS CONTAMINATED; DUST PARTICLES WERE PRESENT. THE CONDITION OBSERVED IN THE LENS RECEIVED IS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE PATIENT'S EYE. THE INFORMATION DOES NOT INDICATE ANY RELATIONSHIP WITH IOL MANUFACTURING. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS OR NONCONFORMITIES. THE DOCUMENTATION SHOWED THAT THE PRODUCTION ORDER WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS AT THE TIME OF THIS REPORT HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS REQUIRED TO BE EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE AS THE PATIENT WAS UNABLE TO TOLERATE HALOS AND GLARE THEY EXPERIENCED. THE IOL WAS USED WITH A NON-AMO CARTRIDGE. THE IOL WAS REPLACED WITH A ZCB00 LENS OF 23.5 DIOPTER POWER (SERIAL NUMBER (B)(4)). IN ADDITION, IT WAS STATED THAT THERE WERE NO SUTURES USED AND NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT'S VISION WAS STATED TO BE BETTER AFTER THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325004 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention