BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 8011159 · Received October 28, 2018

    Report

    Report Number
    9615030-2018-00009
    Event Type
    Injury
    Date Received
    October 28, 2018
    Date of Event
    June 28, 2018
    Report Date
    September 26, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE RESIDUAL STROMAL TISSUE IN BOTH EYES WERE NOT DETECTED AND EXTRACTED BECAUSE THE PATIENT'S EYE BUTTONS APPEARED CIRCULAR WHEN LAID OUT AFTER REMOVAL; HOWEVER, THE PROCEDURE IS TO SPREAD OUT THE LENTICULE AFTER REMOVAL ON TOP OF THE CORNEA IN ORDER TO CHECK FOR COMPLETE REMOVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THREE MONTHS AFTER PERFORMING A REFRACTIVE SURGERY A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT WAS COMPLAINING OF POOR VISUAL ACUITY. IT WAS REPORTED THAT ON (B)(6) 2018, THE HCP DILATED THE PATIENT, AND HE OBSERVED A SMALL CRESCENT SHAPED LENTICULE FRAGMENT IN THE SUPERIOR NASAL PORTION OF THE RIGHT EYE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2018 THE LENTICULE FRAGMENT WAS REMOVED FROM THE PATIENT'S RIGHT EYE BY THE HCP. THE HCP REPORTED THAT THE PATIENT'S LEFT EYE WILL BE REVISITED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851883 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other