BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 1963133 · Received January 18, 2011

    Report

    Report Number
    2648035-2010-00268
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P98040/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS RECEIVED AND INSPECTED, LENS WAS CUT IN HALF WITH ONE BROKEN HAPTIC. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. IN FOLLOW-UP WITH THE ACCOUNT WE ARE NOT ABLE TO DETERMINE THE CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT. THE INVESTIGATION IS INCONCLUSIVE. ALL INFORMATION CURRENTLY AVAILABLE IS CONTAINED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING THE INTRAOCULAR LENS (IOL) INTO THE PATIENT'S EYE, THE PATIENT'S CAPSULAR BAG RUPTURED. THE LENS WAS REMOVED AND AN ALTERNATE LENS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS 1-PIECE MONOFOCAL IOL HQL ABBOTT MEDICAL OPTICS ZCB00

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention