BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4745732 · Received May 4, 2015

    Report

    Report Number
    3003288808-2015-05326
    Event Type
    Injury
    Date Received
    May 4, 2015
    Report Date
    July 14, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE LOG FILE WAS NOT REVIEWED, BECAUSE NO DAY OF TREATMENT WAS PROVIDED AND ROOT CAUSE DETERMINED (BASED ON REPORT) TO BE ABNORMAL USE. THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR AND AFTER THE DATE OF TREATMENT. AT THE VISIT ON SITE THE FIELD SERVICE ENGINEER (=FSE) PERFORMED A ROUTINE MAINTENANCE AND NOTHING UNUSUAL WAS SHOWN, I.E. THE DEVICE WORKED AS EXPECTED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. THE ASSOCIATED DEVICE WAS RELEASED BASED ON MANUFACTURER ACCEPTANCE CRITERIA. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE PRODUCT WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE WAS DETERMINED TO BE ABNORMAL USE, BECAUSE THE SYSTEM HAS A SPECIFIC FEATURE FOR PTK, BUT THE USER DID NOT USE THIS FOR THE PTK TREATMENT.

    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 CUSTOMER REPORTED AN UNSATISFYING POSTOPERATIVE RESULT ONE WEEK AFTER PHOTO THERAPEUTIC KERATECTOMY (PTK) TREATMENT. ACCORDING TO A COMPANY REPRESENTATIVE, INSTEAD OF USING THE PTK MODE AVAILABLE IN THE SYSTEM, THE SURGEON PERFORMED TREATMENT AS HE WAS USED TO WITH A PREVIOUS SYSTEM FROM ANOTHER MANUFACTURER. THE SURGEON CONDUCTED A COMBINED TREATMENT WITH A CORRECTION OF -0.75 FOR THE FIRST TREATMENT AND +0.75 FOR THE SECOND. THE POSTOPERATIVE RESULT WAS -1.50. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290930 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other