BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS 1-PIECE

    MDR report key: 1760364 · Received July 18, 2010

    Report

    Report Number
    2648035-2010-00134
    Event Type
    Injury
    Date Received
    July 18, 2010
    Date of Event
    June 30, 2010
    Report Date
    June 30, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS NOT RECEIVED FOR ANALYSIS. THE CAUSE OF THIS EVENT REASONABLY SUGGESTS IT IS NOT MANUFACTURING RELATED BUT INSTEAD USER RELATED, THE INCORRECT INSERTION CARTRIDGE WAS USED TO IMPLANT THE LENS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED THE PATIENT'S POSTERIOR CAPSULAR BAG TORE DURING INSERTION OF THE INTRAOCULAR LENS(IOL). THE REASON STATED WAS THAT THE WRONG INSERTION CARTRIDGE WAS USED. THE CAPSULAR TEAR WAS REPAIRED AND AN ALTERNATE IOL IMPLANTED. THE PATIENT EXPERIENCED NO FURTHER COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention