BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 17673869 · Received September 1, 2023

    Report

    Report Number
    9615030-2023-00007
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    June 29, 2023
    Report Date
    September 1, 2023
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    UDI-DI
    04049471095036
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONCLUDED THAT A TOO LONG EXPOSURE TIME OF ANESTHETICS (EYE DROPS) WAS THE ROOT CAUSE FOR THE REPORTED EVENT. THIS LED TO A DEHYDRATION OF THE CORNEA. THE CORNEA SHRUNK DOWN AND THE RESULTING CUT WAS MADE TOO DEEP. DESCRIPTION OF CHANGES: FIELD G3: DATE ADDITIONAL INFORMATION WAS RECEIVED BY THE MANUFACTURER. FIELD G6: UPDATED TO "FOLLOW-UP, # 1", CHECKED "30 DAYS". FIELD H2: SELECTED "ADDITIONAL INFORMATION". FIELD H10: ADDED DESCRIPTION OF CHANGES.

    Additional Manufacturer Narrative · 0

    THE ISSUE LIKELY OCCURRED DUE TO THE PATIENT'S ANATOMICAL PECULIARITIES. A DEVICE MALFUNCTION CAN BE EXCLUDED. WITH THE CURRENT INFORMATION, THERE IS NO INDICATION OF ANY MALFUNCTION OF THE ZEISS DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED SURGICAL OUTCOME.

    Description of Event or Problem · 0

    ON (B)(6) 2023, WE RECEIVED A REPORT THAT A FOLLOW UP OD SURGERY WAS PERFORMED ON A PATIENT. THE PATIENT HAD UNDERWENT A PTK SURGERY AFTER HAVING SMILE SURGERY ON (B)(6) 2023. THE PTK PROCEDURE IS AN AFTER-TREATMENT AND AN ADDITIONAL MEDICAL INTERVENTION WHICH WAS TAKEN IN ORDER TO PREVENT PERMANENT AND/OR TEMPORARY IMPAIRMENT. AT PRESENT, THE PATIENT IS STILL IN THE RECOVERY PERIOD AFTER SURGERY, AND NO MORE TREATMENTS HAVE BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2225119 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) VISUMAX, MOD. 75 04049471095036

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Prefer Not To Disclose Required Intervention