BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M

    MDR report key: 5488388 · Received March 9, 2016

    Report

    Report Number
    3010300699-2016-00011
    Event Type
    Injury
    Date Received
    March 9, 2016
    Report Date
    July 15, 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
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT WAS PERFORMED. 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SAMPLE WAS NOT RETURNED. REQUESTED DATA NOT PROVIDED. NO TECHNICAL ROOT CAUSE COULD BE DETERMINED BASED ON THE INFORMATION THAT WAS PROVIDED. CONTRIBUTING FACTORS FOR REPORTED EVENT COULD BE A CHANGING OF DOCTOR/MICROSCOPE POSITION AFTER CONFIRMATION OF THE REGISTRATION OR GUIDELINES OF AN APPROPRIATE SURGERY IMAGE WHERE NOT FOLLOWED (E.G TOO LOW MICROSCOPE ILLUMINATION, ZOOM LEVEL OF THE MICROSCOPE TOO HIGH OR TOO LOW OR BAD CENTRATION OF THE EYE DURING THE SURGERY). MOST LIKELY THE ROOT CAUSE IS USE ERROR. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT THE IMPLANTATION AXIS WAS NOTICED TO BE NOT CORRECT IN A POOL OF PATIENTS AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT. FOR THREE OF THESE PATIENTS, A SECONDARY INTERVENTION WAS PERFORMED IN ORDER TO CORRECT THE GAP. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED. THIS IS ONE OF THREE REPORTS BEING FILED FOR THE SAME FACILITY AND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144556 VERION DIGITAL MARKER M MARKER, OCULAR FTH WAVELIGHT GMBH (AGPS) X-SPM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R