BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 3223033 · Received July 12, 2013

    Report

    Report Number
    9614546-2013-00116
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE MANUFACTURING RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS OR NONCONFORMITIES. DIOPTER MEASUREMENT RECORDS FOR THIS PARTICULAR LENS WERE VERIFIED AND SHOWN TO BE WITHIN SPECIFICATIONS. THE PRODUCTION ORDER HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. A VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, WHICH IS A CONDITION CONSISTENT WITH A LENS THAT HAS BEEN EXPLANTED FROM THE EYE. NO OPTICAL DEVIATIONS ON THE RECEIVED OPTIC PARTS COULD BE FOUND. DUE TO THE CONDITION OF THE RETURNED LENS, NO FURTHER TESTING COULD BE PERFORMED. THE LENS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. CORRECTED DATA: EXPIRATION DATE: 07/06/2016; DEVICE MANUFACTURE DATE: 08/06/2012. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE LEFT EYE OF THE PATIENT AFTER SHE EXPERIENCED UNEXPECTED POST-OPERATIVE REFRACTION. IN FOLLOW UP THE PATIENT WAS DOING FINE WITH THE NEW LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322633 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention