BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3930315 · Received July 11, 2014

    Report

    Report Number
    2648035-2014-00339
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXPLANT DATE: LENS REMAINS IMPLANTED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: MANUFACTURING RECORDS WERE REVIEWED. ALL PROCESS OPERATIONS PRESENTED IN THE MANUFACTURING RECORD FROM GENERATION TO BOXING WERE IN COMPLIANCE WITH MANUFACTURING INSTRUCTIONS SPECIFICATIONS. ALL TESTS RESULTS SHOWED A PASS CONDITION. NO DEVIATION OR NON-CONFORMANCE (NCR) RELATED TO THE CUSTOMER CLAIM WAS GENERATED. CORRECTION: HEALTH PROFESSIONAL SHOULD HAVE BEEN CHECKED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A SURGEON THAT A PATIENT WHO WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE HAS PROGRESSIVE CALCIFICATION OF THE IOL. HE NOTED THAT THE PATIENT EXPERIENCES GLARE AND VISUAL SYMPTOMS TYPICALLY ASSOCIATED POSTERIOR CAPSULAR OPACITY. A ND:YAG OF POSTERIOR CAPSULE OPACIFICATION FAILED TO IMPROVE THE OPACITIES. OUTCOME SIGNIFICANTLY INTERFERES WITH SOME ACTIVITIES OF DAILY LIFE. AT THIS TIME THE IOL REMAINS IMPLANTED BUT CONSIDERATION OF A LENS EXCHANGE IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406305 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other