BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS CL

    MDR report key: 2063608 · Received April 19, 2011

    Report

    Report Number
    2648035-2011-00070
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P880081/S032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LEARNED FROM THE ACCOUNT CONTACT THAT THE LENS WAS SCRAPPED BY THE ACCOUNT AFTER EXPLANT. ORIGINAL IMPLANT OF 20.5 D WAS REPLACED WITH A 19.5 D SUGGESTING THIS EVENT WAS NOT CAUSED BY THE LENS. THERE WERE NO PATIENT INJURY OR COMPLICATIONS. ALL CURRENTLY AVAILABLE INFORMATION IS INCLUDED IN THIS REPORT. LENS SCRAPPED AT THE ACCOUNT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED INTRAOCULAR LENS HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. PRIOR TO RELEASE THE LENS MET ALL MANUFACTURING SPECIFICATIONS. A REVIEW OF THE IMPLANT DATABASE SHOWS THE IOL WAS EXCHANGED FOR A ONE DIOPTER LOWER POWER LENS OF THE SAME MODEL. OUR INVESTIGATION TO DATE SUGGESTS THIS EVENT WAS NOT CAUSED BY THE LENS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE SURGERY CENTER THAT A PATIENT'S INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION 3 WEEKS AFTER INITIAL IMPLANT. REASON STATED WAS WRONG DIOPTER POWER WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention