BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 7001480 · Received November 3, 2017

    Report

    Report Number
    9615030-2017-00024
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    May 12, 2017
    Report Date
    October 25, 2017
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) REPORTED A BAD REFRACTIVE OUTCOME. THE PATIENT'S POST-OPERATIVE UCVA (UNCORRECTED VISUAL ACUITY) FOR OD AFTER VISUMAX SMILE TREATMENT WAS 20/50. THE PATIENT LOST THREE LINES OF BSCVA (BEST SPECTACLE-CORRECTED VISUAL ACUITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778106 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other