BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 2103155 · Received May 25, 2011

    Report

    Report Number
    2648035-2011-00094
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 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

    CORRECTION MADE, DEVICE EVALUATED BY MANUFACTURER: ALL PERTINENT INFORMATION AVAILABLE TO AMO HAS BEEN SUBMITTED. SHOULD NEW INFORMATION BE RECEIVED THAT CHANGES THE FACTS AND/OR CONCLUSION OF THIS REPORT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED IOL WAS MEASURED FOR DIOPTER AND WAS CORRECT AS LABELED, 20.5 D. 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 AVAILABLE INFORMATION IS PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS REMOVED AND REPLACED WITHOUT COMPLICATION (B)(6) AFTER IMPLANT. REASON STATED WAS IMPROPER IOL POWER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention