BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2201259 · Received August 11, 2011

    Report

    Report Number
    2648035-2011-00161
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P99080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETED BY THE MANUFACTURER: THE RETURNED INTRAOCULAR LENS WAS RETURNED AND ANALYSIS SHOWS THE DIOPTER IS CORRECT AS LABELED, 23.0D. ALL OTHER OPTICAL MEASUREMENTS MET SPECIFICATION. OUR INVESTIGATION IDENTIFIED NO PRODUCT DEFICIENCY, SUGGESTING THAT THIS EVENT WAS NOT CAUSED BY THE IOL. ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS WAS EXPLANTED 10 WEEKS AFTER THE INITIAL IMPLANT. THE LENS WAS EXCHANGED FOR A LOWER DIOPTER LENS OF THE SAME MODEL. REASON STATED WAS IMPROPER IOL POWER.

    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 73 YR Required Intervention