BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 10283691 · Received July 16, 2020

    Report

    Report Number
    3010300699-2020-00005
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    April 10, 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

    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. IT WAS DETERMINED THAT USER ERROR LEAD TO THE MISALIGNMENT OF THE LENS. THE SELECTED SUPERIOR ORIENTATION ON THE PLANNING SCREEN DOES NOT MATCH THIS ORIENTATION OF THE EYE. FOLLOWED BY A WRONG REGISTRATION PROPOSAL CONFIRMED OR MANUALLY SET, THIS LEAD TO A WRONG TORIC ALIGNMENT OVERLAY. USER ERROR, DUE TO INCORRECT MICROSCOPE ORIENTATION AND INCORRECT REGISTRATION. 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. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES PATIENT SIX AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749338 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention