BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES

    MDR report key: 3954743 · Received July 18, 2014

    Report

    Report Number
    3003288808-2014-01119
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 24, 2014
    Report Date
    June 20, 2014
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    LZS
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    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. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY THE GUIDING SYSTEM PROJECTED WRONGLY THE ORIENTATION AXIS. THE MARKINGS IN THE SURGEON'S MICROSCOPE AND IN THE SYSTEM'S DISPLAY, WERE PERMANENTLY CHANGING, THUS MAKING DIFFICULT FOR THE SURGEON TO GUESS WHICH THE CORRECT TORIC ALIGNMENT AXIS WAS. THE SURGEON REPORTED THAT SHE DIDN'T KNOW EXACTLY WHICH AXIS FOR THE TORIC ALIGNMENT WAS THE CORRECT ONE, SO SHE CHOOSE ONE OF THE MULTIPLE AXIS DISPLAYED BY THE SYSTEM. DUE TO THIS EVENT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED WITH A 16 DEGREES AXIS ERROR. THIS WAS IDENTIFIED ONLY IN THE POST-OPERATORY CONTROL OF THE PATIENT ONE DAY BEFORE SURGERY AND ALSO AFTER A MONTH. THE AFFECTED EYE WAS THE LEFT EYE (OS). THE TOTAL DURATION OF THE SURGERY WAS OF 10 MINUTES. THE VISCOELASTIC WAS REMOVED USING BIMANUAL IRRIGATION/ASPIRATION, INCLUDING UNDERNEATH THE IOL. THE SURGEON ALSO REPORTED THAT THERE WAS VISUAL IMPACT FOR THE PATIENT (RESIDUAL ASTIGMATISM) CORRECTED WITH EYE GLASSES AND THAT THE PATIENT DID NOT WANT TO HAVE A NEW SURGERY FOR THE IOL ROTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423184 VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES CAMERA, STILL, MICROSURGICAL LZS WAVELIGHT GMBH (AGPS) X-SPM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IOL ACRYSOF TORIC| METHYLCELLULOSE VISCOELASTIC