BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2802904 · Received October 24, 2012

    Report

    Report Number
    9614546-2012-00181
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    MFK
    PMA / PMN Number
    P080010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS- CONCLUDING INSPECTION OF THE RETURNED INTRAOCULAR LENS (IOL) INDICATE THAT ONE (1) HAPTIC WAS DISTORTED. IN ADDITION, THERE APPEARED TO BE EVIDENCE OF BLOOD AND VISCOELASTIC. PRIOR TO RELEASE TO MARKET THE INTRAOCULAR LENS MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT OF AN INTRAOCULAR LENS (IOL) DUE TO A DISTORTED HAPTIC ON THE SAME DAY THE IOL WAS IMPLANTED. IT WAS STATED THAT AN INCISION ENLARGEMENT WAS MADE WHICH DID NOT REQUIRE SUTURES. IN ADDITION, THE NEW LENS THAT WAS IMPLANTED WAS ALSO A MODEL ZMA00 IOL. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS STATED TO BEING DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention