BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1994190 · Received February 16, 2011

    Report

    Report Number
    2648035-2011-00020
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS DISCARDED AT THE SURGERY CENTER AND NOT RETURNED FOR ANALYSIS. IN FOLLOW-UP WITH THE ACCOUNT IT WAS DETERMINED THE IOL WAS NOT THE CAUSE OF THIS EVENT, PATIENT HAD A WEAK CAPSULAR BAG THAT COULD NOT SUPPORT THE IOL. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE INTRAOCULAR LENS WAS IMPLANTED AND REMOVED IN THE SAME SURGERY DUE TO A WEAK CAPSULAR BAG. PATIENT WILL RETURN TO HAVE A LENS SUTURED IN. THE INITIAL IMPLANT WOULD NOT STAY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS CL MONOFOCAL LENS HQL ABBOTT MEDICAL OPTICS Z9002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention