BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2800688 · Received October 22, 2012

    Report

    Report Number
    2648035-2012-00322
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    August 22, 2012
    Report Date
    October 4, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    REPORTEDLY, DURING IMPLANTATION OF THE INTRAOCULAR LENS (IOL) THERE WAS A POSTERIOR BAG COLLAPSE. WITHIN THE SAME PROCEDURE THE SURGEON DECIDED TO REPLACE THE ORIGINAL INTRAOCULAR LENS (IOL) WITH A LENS THAT WAS A 22.5 DIOPTOR IN ORDER TO PLACE IT IN THE SULCUS. THERE WERE NO FURTHER COMPLICATIONS, AND IT WAS STATED THAT THE PATIENT WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention