BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE 200HZ EXCIMER LASER

    MDR report key: 4930866 · Received July 22, 2015

    Report

    Report Number
    3003288808-2015-05983
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    March 12, 2015
    Report Date
    October 16, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 REQUETED BUT NOT RECEIVED TO DATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED: EVALUATION SUMMARY: NO MATERIAL WAS RETURNED FOR EVALUATION. A CLINICAL APPLICATION SPECIALIST IDENTIFIED DURING THE TRAINING OF THE PERSONAL ON (B)(6) 2015 THAT THE ENERGY SETTINGS WERE CORRECT, CONFIRMED BY THE PASSED FLUENCE TESTS. LOG FILE REVIEW SHOWED THE TREATMENT WAS COMPLETED TO 100 %. ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS FOR THE RESPECTIVE TREATMENT. THE SYSTEM HISTORY SHOWED THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR AND AFTER THE DATE OF TREATMENT. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS 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 CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    A NURSE REPORTED CASES OF OVERCORRECTION FOLLOWING REFRACTIVE SURGERY. THIS CASE IS FOR A PATIENT'S LEFT EYE WHO EXPERIENCED AN HYPERCORRECTION, AT FIVE MONTHS POST LASIK TREATMENT. COMPANY REPRESENTATIVE INFORMED THAT THE NOMOGRAM WAS INCORRECTLY APPLIED AND THE ENERGY WAS ADJUSTED TOO HIGH AT THE FLUENCE TEST BY THE CUSTOMER. TRAINING WAS SCHEDULED FOR SURGEONS INVOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476429 ALLEGRETTO WAVE 200HZ EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other