BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBSU MICROKERATOME

    MDR report key: 21624649 · Received March 17, 2025

    Report

    Report Number
    9615659-2025-00001
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    March 17, 2025
    Manufacturer
    MORIA SA
    Product Code
    HMY
    PMA / PMN Number
    K981741
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE MICROKERATOME SYSTEM TESTED ACCEPTABLE, THE CBSU BLADE WAS NOT SAVED AND THEREFORE NOT TESTED. THE LOT OF THE CB BLADE WAS LIKELY 2212103 (WHICH WAS THE LAST LOT SHIPPED TO THE CUSTOMER, BUT NOT CONFIRMED).

    Description of Event or Problem · 0

    HEALTHCARE PROVIDER REPORTED SMALL/INCOMPLETE FLAP ON RIGHT EYE. ALSO STATED: ABORTED SURGERY, WILL DO PRK IN 3-4 MONTHS; DID NOT SAVE BLADE; SENT FULL SYSTEM, AND CLINICAL DATA FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566894 CBSU MICROKERATOME CBSU MICROKERATOME HMY MORIA SA 19312/130 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Unknown Required Intervention CB TURBINE REF. (B)(4).| CBSU FIXATION RING REF. (B)(4).| EVOLUTION CONSOLE REF. (B)(4).| TURBINE HOSE REF. (B)(4).