BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1 MULTIFOCAL

    MDR report key: 2981573 · Received February 27, 2013

    Report

    Report Number
    9614546-2013-00035
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    October 2, 2012
    Report Date
    February 7, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P980040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): MANUFACTURING RECORD REVIEW INDICATES THE BATCH HAS PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS.ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION SHOWED A LENS WHERE THE OPTIC WAS CUT IN HALF, NO OPTICAL DEVIATIONS ON THE OPTIC PARTS COULD BE FOUND. DUE TO THE CONDITION OF THE RETURNED LENS, THE DIOPTER POWER COULD NOT BE VERIFIED. THE IOL PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND WAS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHICH WAS REMOVED AND REPLACED IN A SECONDARY DUE TO PATIENT DISSATISFACTION. IT WAS STATED THAT THE INCISION WAS NOT ENLARGED DURING THE EXPLANT. NO COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84509 TECNIS 1 MULTIFOCAL MULTIFOCAL IOLS MFK ABBOTT MEDICAL OPTICS ZMB00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention