BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES

    MDR report key: 4024527 · Received August 1, 2014

    Report

    Report Number
    3010300699-2014-00002
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    WAVELIGHT GMBH (AGPS)
    Product Code
    FTH
    PMA / PMN Number
    EXERR
    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 INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THAT AFTER CATARACT SURGERY SHE IDENTIFIED A DEVIATION IN THE AXIS FOR THE IMPLANTED TORIC IOL IN THREE PATIENTS. DURING SURGERY, SHE SAW A ROTATION OF THE FINAL AXIS COMPARED WITH THE INITIALLY PLANNED AXIS. THIS LED TO RESIDUAL ASTIGMATISM THAT WAS CORRECTED WITH EYE GLASSES. FOR THIS PT SURGEON REPORTED A JUMP ON THE MARKS FOR THE INCISION OF 30 DEGREES. THE SURGEON INDICATED THE POSTOPERATIVE ASTIGMATISM WAS DUE TO THE SYSTEM MAKINGS AND NOT DUE TO A POSTOPERATIVE IOL ROTATION. ADDITIONAL INFO WAS RECEIVED FROM THE SURGEON. DURING SURGERY, MARKINGS IN THE MICROSCOPE AND IN THE DISPLAY WERE PERMANENTLY CHANGING, THUS MAKING IT DIFFICULT TO GUESS WHICH WAS THE CORRECT TORIC ALIGNMENT AXIS. THE SURGEON CHOSE ONE OF THE MULTIPLE AXIS DISPLAYED AND POSTOPERATIVELY THE IOL PRESENTED A ROTATION OF 12 DEGREES DEVIATION FROM THE PREOPERATORY AXIS SUGGESTED BY THE DIGITAL MARKER (164 DEGREE INSTEAD OF 176 DEGREE). THE ROTATION WAS OBSERVED ON THE FIRST POSTOPERATIVE DAY AND PERSISTED ONE MONTH AFTER SURGERY. THE PT WAS NOT WILLING TO UNDERGO IOL REPOSITIONING. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451645 VERION DIGITAL MARKER M FOR ZEISS MICROSCOPES CAMERA, STILL, MICROSURGICAL FTH WAVELIGHT GMBH (AGPS) X-SPM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention AVODART| UNK ACRYSOF TORIC IOL| IZODIENT| ATENOLOL