BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECNIS

    MDR report key: 3050478 · Received April 10, 2013

    Report

    Report Number
    2648035-2013-00158
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    November 29, 2012
    Report Date
    March 20, 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 WAS RETURNED TO THE MANUFACTURER. VISUAL EXAMINATION SHOWED THE LENS HAD SURFACE RESIDUALS ADHERED TO BOTH SIDES OF OPTIC BODY COMPATIBLE WITH HANDLING LENS IN AN UNSTERILE ENVIRONMENT. DIOPTER VERIFICATION RESULTS SHOWED THAT THE LENS DIOPTER CORRESPONDS TO A 22.0 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 A PATIENT HAD AN INTRAOCULAR LENS EXPLANTED FROM THE RIGHT EYE DUE TO UNEXPECTED POST-OPERATIVE REFRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152289 TECNIS MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS ZA9003

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention