BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 10825585 · Received November 11, 2020

    Report

    Report Number
    9615030-2020-00014
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    October 14, 2020
    Report Date
    October 14, 2020
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER EVALUATED THE AVAILABLE INFORMATION AND COULD NOT FIND A COMPLAINT, WHICH WOULD MATCH WITH THIS EVENT. NO FURTHER DATA, (E.G. ANY CONTACT DATA OF PATIENT, HEALTH CARE PROFESSIONAL LOCATION, OR USER FACILITY) COULD BE OBTAINED. NOR ANY OTHER DEVICE RELATED DATA IS AVAILABLE. THE PATIENT DID NOT ALLEGE A DEVICE PROBLEM. THE USER MANUAL FOR VISUMAX IDENTIFIES SOME OF THE SIDE EFFECTS DESCRIBED BY THE PATIENTS AS KNOWN CONTRAINDICATION AND SIDE EFFECTS THAT CAN BE ASSOCIATED WITH THE VISUMAX LASER PROCEDURE. THE USER MANUAL ALSO ADVISES THE HEALTH CARE PROFESSIONAL TO PERFORM A CLINICAL EVALUATION TO IDENTIFY ANY ADDITIONAL SIDE EFFECTS FROM THE RELEVANT TECHNICAL LITERATURE AND MEDICAL ASSOCIATIONS. "SIDE-EFFECTS AND COMPLICATIONS ARE NOT LIMITED TO THIS LIST. PLEASE CONSULT MEDICAL LITERATURE AND ASSOCIATIONS FOR ADDITIONAL SIDE EFFECTS".

    Description of Event or Problem · 1

    CARL ZEISS MEDITEC, INC. RECEIVED FROM THE FDA VOLUNTARY EVENT REPORT MW5096471, WHICH WAS SUBMITTED BY A PATIENT. THE PATIENT REPORTED EXPERIENCING SIDE EFFECTS POST LASIK SURGERY IN 2017. THE SIDE EFFECTS DESCRIBED BY THE PATIENT ARE DRY EYE, FLOATERS, HALOS, STARBURST, GLARE AND POOR NIGHT VISION IN BOTH EYES. THE PATIENT FURTHER REPORTED THAT THESE SYMPTOMS HAVE CAUSED PERSISTENT ANXIETY, PAIN AND DISCOMFORT, ADVERSELY AFFECTING EVERYDAY FUNCTION, ABILITY TO WORK, QUALITY OF LIFE MENTAL HEALTH AND GENERAL WELL BEING. THE DEVICES LISTED FOR TREATMENT WERE THE VISUMAX FEMTOSECOND LASER (MANUFACTURED BY CARL ZEISS MEDITEC) AND THE NIDEK EC-500 EXCIMER LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287647 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other