BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOFOCAL IOLS

    MDR report key: 6739244 · Received July 24, 2017

    Report

    Report Number
    2648035-2017-01339
    Event Type
    Malfunction
    Date Received
    July 24, 2017
    Report Date
    July 24, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HQL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT THERE SOME CASES WHERE THERE WERE A FEW SPECKS INFERIORLY ON THE INTRAOCULAR LENS (IOL) BUT COULD NOT BE SPECIFIC. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519464 MONOFOCAL IOLS HQL ABBOTT MEDICAL OPTICS

    Patients

    Seq Age Sex Outcome Treatment
    1