BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3200521 · Received July 1, 2013

    Report

    Report Number
    2648035-2013-00273
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO OUR MANUFACTURING FACILITY FOR INSPECTION. THE LENS WAS RECEIVED IN CUT IN HALF AND WAS CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED. THE RETURNED LENS WAS INSPECTED AT 10X MICROSCOPE MAGNIFICATION WITH THE VISUAL INSPECTION REVEALING THAT THE LENS WAS RECEIVED WITH SURFACE RESIDUALS (DEBRIS/PARTICLES) ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH USE OF THE LENS SUCH AS AN IMPLANT AND LATER EXPLANT. DUE TO THE RETURNED CONDITION OF THE LENS, IT WAS NOT POSSIBLE TO MEASURE THE LENS. NO MANUFACTURING RELATED DEFECT THAT COULD HAVE CAUSED THE REPORTED EVENT/COMPLAINT WAS IDENTIFIED IN THE RETURNED LENS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECONDARY PROCEDURE TO REMOVE THE INTRAOCULAR LENS (IOL) AFTER APPROXIMATELY SIX (6) WEEKS DUE TO BLURRY VISION. BLURRY VISION WAS REPORTED AT THE PATIENT'S ONE WEEK POST OPERATIVE VISIT. ANOTHER LENS WAS IMPLANTED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300062 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention