BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRO OCULYZER

    MDR report key: 7819480 · Received August 27, 2018

    Report

    Report Number
    3003288808-2018-01514
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Report Date
    December 6, 2018
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    MXK
    PMA / PMN Number
    K071183
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. THE ROOT CAUSE COULD NOT BE IDENTIFIED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE INDEX OF HEIGHT DECENTRATION (IHD) WAS ABNORMAL. THE VALUE IS GREATER THAN 0.014 IN SIX TO SEVEN PATIENTS OUT OF TEN PATIENTS. THE ISSUE WAS DISCOVERED IN NORMAL EYES TOO. ADDITIONAL INFORMATION RECEIVED STATES THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661950 ALLEGRO OCULYZER DEVICE, ANALYSIS, ANTERIOR SEGMENT MXK WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other