BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 10211973 · Received June 30, 2020

    Report

    Report Number
    3010300699-2020-00002
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    April 24, 2020
    Report Date
    August 25, 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

    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. DATA COLLECTION WAS RECEIVED AND THE DATA WAS INVESTIGATED. BASED ON THE DATA THE SURGEON OPERATED FROM A SLIGHTLY INFERIOR POSITION. THE SELECTED TEMPORAL ORIENTATION ON THE PLANNING SCREEN DOES NOT MATCH THIS ORIENTATION OF THE EYE. FOLLOWED BY A WRONG REGISTRATION PROPOSAL CONFIRMED, THIS LEAD TO A WRONG TORIC ALIGNMENT OVERLAY. USER ERROR, THE SURGEON OPERATED FROM A SLIGHTLY INFERIOR POSITION, WHICH IS NOT AVAILABLE IN THE DEVICE AND AN INCORRECT REGISTRATION WAS CONFIRMED/MANUALLY SET. 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 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 WILL BE SCHEDULED TO FIX THE DEVIATION AT A LATER DATE. ADDITIONAL INFORMATION RECEIVED STATES THE INTRAOCULAR LENS DEVIATION WAS FIXED AND THE PATIENT HAS RECOVERED. THERE ARE FOUR RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES PATIENT ONE AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674750 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other