BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELIGHT OCULYZER II DIAGNOSTIC DEVICE

    MDR report key: 20307634 · Received September 26, 2024

    Report

    Report Number
    3003288808-2024-00251
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Report Date
    December 20, 2024
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION PROVIDED IN D.4. UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER ADDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. LASER WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER WAS ON FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. SYSTEM MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. DURING ONSITE VISIT THE FIELD SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION. ALL READINGS WERE WITHIN SPECIFICATION. FIELD SERVICE ENGINEER PERFORMED SYSTEM VERIFICATION AS PER SERVICE INSTALLATION RECORD. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED CONCLUSIVELY, AS NO PROBLEM OR MALFUNCTION COULD BE DETECTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    H.6.: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE MEASUREMENTS PROVIDED BY SYSTEM WERE A BIT OFF DURING UNKNOWN TIMING OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2238659 WAVELIGHT OCULYZER II DIAGNOSTIC DEVICE DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA 169LY7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown