BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3051593 · Received April 10, 2013

    Report

    Report Number
    2648035-2013-00163
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 22, 2013
    Report Date
    March 19, 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 INRAOCULAR LENS WAS RETURNED TO THE MANUFACTURER. VISUAL INSPECTION OF THE LENS REVEALED SURFACE RESIDUALS, PARTICLES AND FIBERS ADHERED TO BOTH SIDES OF OPTIC BODY WHICH INDICATES THAT LENS WAS HANDLED IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION: OPTICAL INSPECTION RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDS TO A 24.5 DIOPTER LENS. THE PRODUCT MET THE ACCEPTANCE CRITERIA. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE LEFT EYE AND SWITCHED WITH ANOTHER LENS BECAUSE THE SURGEON FELT THAT THERE WOULD BE A BETTER OUTCOME WITH A DIFFERENT LENS POWER. RESULT OF NEW IMPLANT WAS GOOD; NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152032 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention