BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 10283462 · Received July 16, 2020

    Report

    Report Number
    3010300699-2020-00004
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    May 29, 2020
    Report Date
    August 24, 2020
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    FTH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. DATA COLLECTION WAS RECEIVED AND THE DATA WAS INVESTIGATED. AT THE PLANNING SCREEN, A CORRECT MICROSCOPE ORIENTATION WAS SELECTED AND THE MATCHING REGISTRATION PROPOSAL CONFIRMED. THE DIGITAL MARKER SHOWED THE CORRECT AXIS FOR TORIC ALIGNMENT. AT THE END OF THE INITIAL SURGERY THE LENS WAS CORRECTLY ALIGNED TO THE DESIRED POSITION. A SECOND VIDEO OF THE TOUCH UP SURGERY WAS AVAILABLE THAT SHOWS A SUDDEN MISALIGNMENT OF THE LENS. POTENTIALLY, THE LENS WAS ROTATED AFTER THE INITIAL SURGERY. DEVICE WORKED AS INTENDED. IT IS UNKNOWN WHY LENS ROTATED AFTER SURGERY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATES THAT HE AXIS DEVIATION WAS FIXED WITH DATA OBTAINED FROM THE SYSTEM DURING THE INITIAL PROCEDURE. THE AXIS CHANGED FROM 32 DEGREES TO 4 DEGREES AFTER SURGERY. THE PATIENT IS RECOVERED.

    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 CUSTOMER REPORTED THAT IT WAS LATER FOUND THAT A PATIENT'S VISUAL ACUITY HAD BEEN UNABLE TO BE PROPERLY ADJUSTED DUE TO AXIS DEVIATION AFTER INSERTION OF A TORIC INTRAOCULAR LENS FOLLOWING THE GUIDANCE DISPLAYED BY THE SYSTEM. IT IS UNKNOWN IF THE DEVIATION WAS CAUSED BY THE CONSOLE OR THE USER. THE PATIENT IS UNRECOVERED. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748962 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention