BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 12297344 · Received August 9, 2021

    Report

    Report Number
    3010300699-2021-00003
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 29, 2021
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    FTH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN INCORRECT METHOD CODE WAS REPORTED ON MANUFACTURER REPORT NUMBER (B)(4) AND THE CORRECT CODE IS BEING REPORTED ON THIS MANUFACTURER REPORT. 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. ROOT CAUSE IS USER ERROR. INCORRECT MICROSCOPE ORIENTATION WAS SELECTED FOR THE FIRST SURGERY. DEVICE BEHAVED AS INTENDED. 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. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED A DEVIATION IN AXIS WAS DISPLAYED ON DIGITAL MARKER MICROSCOPE (DMM) DURING SURGERY. THE DOCTOR HAD DOUBTS ABOUT INSERTING THE INTRAOCULAR LENS (IOL) AT THE AXIS DISPLAYED ON DMM. AXIS DEVIATION OF ABOUT 20 DEGREES WAS FOUND POST SURGERY WHEN IOL POSITION WAS CHECKED. AN OPERATION TO ADJUST THE AXIS WAS LATER PERFORMED. THE SURGERY WAS COMPLETED. THE DOCTOR SAID THERE MIGHT HAVE BEEN A DIFFERENCE BETWEEN THE POSITION OF A MICROSCOPE DURING SETUP AND ITS ACTUAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191636 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other| R