BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX

    MDR report key: 11042178 · Received December 18, 2020

    Report

    Report Number
    9615030-2020-00023
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 20, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DUE TO INCORRECT HANDLING OF THE DEVICE. THE OBJECTIVE LENS OF THE DEVICE HAD RESIDUE OF BALANCE SALT SOLUTION (BSS) WHICH IS USED TO RINSE PATIENT'S EYES. IT HAS BEEN COMMUNICATED TO THE HCP TO BE VERY CAUTIOUS TO NOT SPLASH BSS ON OR TOUCH THE OBJECTIVE LENS BEFORE, DURING, AND AFTER ANY PATIENT TREATMENT.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A SMILE PROCEDURE USING THE VISUMAX LASER SYSTEM, BLACK SPOTS OCCURRED ON PATIENT'S BOTH EYES. THIS MADE IT DIFFICULT TO SEPARATE THE LENTICULE ON THE LEFT EYE. THE HCP COMMUNICATED THAT THE PATIENT HAD TO COME BACK AT A LATER DATE TO REMOVE THE LENTICULE REMNANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505969 VISUMAX FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention