BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 1971044 · Received January 26, 2011

    Report

    Report Number
    2648035-2010-00274
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 30, 2010
    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

    MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND PATIENT STATUS WITH NO RESPONSE TO DATE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) HAS NOT BEEN RECEIVED FOR ANALYSIS. MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION WITH NO RESPONSE TO DATE. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCOUNT REPORTED THE INTRAOCULAR LENS WAS EXPLANTED. REASON STATED WAS UNKNOWN. REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE TO DATE BEEN UNSUCCESSFUL.

    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