BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 5537484 · Received March 31, 2016

    Report

    Report Number
    3010300699-2016-00014
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    June 23, 2016
    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
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS NOT RETURNED. NO INFORMATION ABOUT THE DEVICE OR SERIAL NUMBER WAS PROVIDED. NO CONTACT INFORMATION PROVIDED; THEREFORE, UNABLE TO OBTAIN FURTHER FOLLOW UP INFORMATION. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO INFORMATION ABOUT THE REPORTED DEVICE WAS PROVIDED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED, BASED ON THE INFORMATION PROVIDED. GENERALLY, AN UNSTABLE OVERLAY CAN BE SEEN IF ILLUMINATION IS TOO DARK OR MICROSCOPE ZOOM LEVEL NOT APPROPRIATE DURING SURGERY. IN SUCH AN EVENT THE SURGEON WOULD NOT BE ABLE TO ACCURATELY SEE TO ALIGN THE LENS. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMOLOGIST REPORTED AN INTRAOCULAR LENS (IOL) AXIS WAS INCORRECTLY ALIGNED ON AN EYE. REPORTER INDICATED A SECONDARY PROCEDURE WAS PERFORMED TO RELOCATE THE IOL TO THE CORRECT AXIS. ADDITIONAL INFORMATION IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194575 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R