BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCULUS PENTACAM

    MDR report key: 23497958 · Received November 7, 2025

    Report

    Report Number
    MW5178635
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    August 22, 2025
    Report Date
    November 4, 2025
    Manufacturer
    OCULUS OPTIKGERATE GMBH
    Product Code
    MXK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A USED PENTACAM HR WITH CSP PRO (SERIAL #(B)(6)) FROM A THIRD-PARTY SELLER IN EARLY 2025. AFTER INSTALLATION I DISCOVERED EVIDENCE OF UNAUTHORIZED FIRMWARE AND COUNTERFEIT LICENSING THAT ENABLED UNAPPROVED DIAGNOSTIC MODULES. I IMMEDIATELY NOTIFIED OCULUS INC. AND COOPERATED FULLY. THEY ACKNOWLEDGED TAMPERING BUT DID NOT RETRIEVE THE UNIT OR FILE A REPORT. I ALSO REPORTED A SIMILAR UNRECOVERED DEMO UNIT SOLD ON EBAY IN (B)(6) 2024. OCULUS WAS UNABLE TO RECOVER IT. DESPITE MY COOPERATION, OCULUS LATER DEMANDED I SIGN A BROAD EXCHANGE AGREEMENT AND THREATENED TO REPORT ME TO THE FDA AND STATE BOARD WHEN I REQUESTED REASONABLE PROTECTIONS. I AM REPORTING THIS AS A DEVICE-INTEGRITY AND TRACEABILITY ISSUE: MULTIPLE UNTRACKED OR TAMPERED OCULUS PENTACAM DEVICES MAY REMAIN IN CIRCULATION, POTENTIALLY AFFECTING DIAGNOSTIC ACCURACY AND PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187114 OCULUS PENTACAM DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK OCULUS OPTIKGERATE GMBH 70700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown