BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOLAS EXCIMER WORKSTATION

    MDR report key: 2274713 · Received September 21, 2011

    Report

    Report Number
    3007606649-2011-00003
    Event Type
    Injury
    Date Received
    September 21, 2011
    Date of Event
    December 17, 2009
    Report Date
    May 19, 2011
    Manufacturer
    TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS
    Product Code
    LZS
    PMA / PMN Number
    P990027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. UNABLE TO PERFORM A DEVICE EVAL OR DRAW CONCLUSIONS REGARDING ROOT CAUSE DUE TO LACK OF INFO. COMPLAINTS OF DRY EYES ARE KNOWN RISKS OF LASIK SURGERY AND ARE IDENTIFIED IN THE DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    MAUDE REPORT (B)(4) WAS RECEIVED FROM THE FDA. A PT REPORTED UNDERGOING LASIK SURGERY IN 2009. APPROX SIX MONTHS POSTOPERATIVELY THE PT BEGAN EXPERIENCING INTERMITTENT DRY EYE SYMPTOMS. AT 11 MONTHS POSTOPERATIVELY THE SYMPTOMS PERSISTED AND WERE REPORTED AS SEVERE AND CONSTANT. THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TECHNOLAS EXCIMER WORKSTATION EXCIMER LASER LZS TECHNOLAS PERFECT VISION GMBH, HEADQUARTERS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S