BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3051610 · Received April 10, 2013

    Report

    Report Number
    2648035-2013-00164
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    October 31, 2012
    Report Date
    March 26, 2013
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    PMA / PMN Number
    P990080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTRAOCULAR LENS (IOL) WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION OF THE LENS REVEALED THAT THE LEADING HAPTIC WAS BENT WHICH IS A CONSEQUENCE OF HAVING THE LENS EXPLANTED. SURFACE RESIDUALS, PARTICLES, AND FIBERS ADHERED TO BOTH SIDES OF OPTIC BODY WHICH INDICATES THAT LENS WAS HANDLED IN AN UNSTERILE ENVIRONMENT. OPTICAL MEASUREMENT: DIOPTER VERIFICATION CORRESPONDS TO A 20.5 DIOPTER LENS; LENS MET SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT CONCERNING A PATIENT WHERE AN INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE AFTER THE PATIENT COMPLAINED OF EXPERIENCING SHADOWS (DYSPHOTOPSIA). NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152134 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention