BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3791001 · Received May 5, 2014

    Report

    Report Number
    9614546-2014-00107
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EXPLANT OF AN INTRAOCULAR LENS.REFRACTIVE SURPRISE.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. THE LENS WAS RETURNED IN ONE PIECE FOR INVESTIGATION. VISUAL INSPECTION USING A MICROSCOPE AT 12X MAGNIFICATION SHOWED THE LENS WAS 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. DIOPTER MEASUREMENT WAS PERFORMED BY A CERTIFIED OPERATOR ACCORDING TO THE OPTICAL SPECIFICATIONS. LENS PASSED THE OPTICAL PROPERTIES FOR A 22.5 DIOPTER INTRAOCULAR LENS. NO DEVIATION WAS DETECTED IN THE COMPLAINT LENS. 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 RIGHT EYE OF A PATIENT IN A SECONDARY PROCEDURE OWING TO A REFRACTIVE SURPRISE. A NEW LENS WAS IMPLANTED IN THE EYE. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269092 TECNIS MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMA00

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention