BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2032874 · Received March 29, 2011

    Report

    Report Number
    2648035-2011-00052
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    February 24, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080/S06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTRAOCULAR LENS (IOL) WAS MEASURED FOR DIOPTER AND IS CORRECT AS LABELED. THE IOL MET ALL SPECIFICATIONS FOR OPTICAL PROPERTIES. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL KNOWN INFORMATION IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INTRAOCULAR LENS WAS RECEIVED AND SENT TO THE MANUFACTURING SITE FOR DIOPTER MEASUREMENT, EVALUATION IS IN PROGRESS. THE LENS MET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. OUR INVESTIGATION SHOWS THE LENS WAS EXCHANGED FOR A LOWER DIOPTER LENS OF THE SAME MODEL. BASED ON THIS INFORMATION AND THE REPORTER'S COMMENT THAT THE IMPROPER IOL POWER WAS IMPLANTED WE DO NOT SUSPECT THAT THE LENS CAUSED THIS ISSUE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE ACCOUNT STATING THAT THE INTRAOCULAR LENS(IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION DUE TO IMPROPER IOL POWER INITIALLY IMPLANTED. THE IOL WAS EXCHANGED FOR A LOWER DIOPTER LENS OF THE SAME MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECNIS MONOFOCAL INTRAOCULAR LENS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention