BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2024243 · Received March 18, 2011

    Report

    Report Number
    2648035-2011-00044
    Event Type
    Injury
    Date Received
    March 18, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS WAS RECEIVED CUT IN PIECES ACROSS THE OPTIC PRECLUDING ANALYSIS. THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. SURGEON STATED THE EVENT IS NOT RELATED TO THE IOL BUT INSTEAD WAS PATIENT RELATED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE INTRAOCULAR LENS (IOL) WAS EXPLANTED WITHOUT COMPLICATION DUE TO THE PATIENT'S UNEXPECTED POST-OP REFRACTION. SURGEON REQUESTED THE LENS BE MEASURED FOR DIOPTER. IN LATER FOLLOW-UP WITH THE SURGEON IT WAS STATED THEY WOULD NO LONGER NEED TO KNOW THE EXACT IOL POWER SINCE THE ISSUES WERE DETERMINED TO BE PATIENT RELATED; PATIENT HAS CORNEAL ISSUES AND THE INITIAL REPORT OF UNEXPECTED POST -OP REFRACTION IS NOT RELATED TO THE IOL. THE CUSTOMER STATED THEY ARE NOT WILLING TO GIVE ANY ADDITIONAL INFORMATION OR THE LENS SERIAL NUMBER.

    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