BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER L

    MDR report key: 6420252 · Received March 21, 2017

    Report

    Report Number
    3010300699-2017-00004
    Event Type
    Injury
    Date Received
    March 21, 2017
    Date of Event
    February 22, 2017
    Report Date
    June 21, 2017
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    FTH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO TECHNICAL ROOT CAUSE COULD BE DETERMINED. A POTENTIAL CONTRIBUTING FACTOR COULD BE RELATED TO AN INCORRECT SELECTION OF DOCTOR SEATING POSITION MAY RESULT IN A WRONG DISPLAYED AXIS SHOWN IN THE OVERLAY AND COULD LEAD TO THE REPORTED PROBLEM. (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 SURGEON REPORTED A CASE OF OBLIQUE ASTIGMATISM POST CATARACT PROCEDURE. THE REPORTER INDICATED THE IMAGE GUIDED SYSTEM RECOMMENDED AXIAL PLACEMENT WAS OFF ALIGNMENT AND DID NOT CORRECT THE CYLINDER POWER. REPORTER INDICATED THE INTRAOCULAR LENS (IOL) WAS ROTATED THREE DAYS LATER, AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204576 VERION DIGITAL MARKER L MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPL ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R