BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3862774 · Received May 28, 2014

    Report

    Report Number
    3003288808-2014-00917
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FIELD AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, AT THIS TIME ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED. THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR TO AND AFTER THE DATE OF TREATMENT. LOGFILES REVIEWS SHOWS THAT ALL TREATMENTS WER COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. THE TECHNICAL INVESTIGATION SHOWS THAT THE DEVICE MEETS THE SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED A CASE OF TRANSIENT LIGHT SENSITIVITY SYNDROME (TLLS), OBSERVED ON A PATIENT'S LEFT EYE AT ELEVEN DAYS POST LASIK TREATMENT. REPORTER INDICATED TOPICAL STEROID EYE DROP DOSAGE WAS INCREASED. PATIENT NOTED INCREASED LIGHT SENSITIVITY IN ALL LIGHTING CONDITIONS, INCREASED TEARING AND PAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314943 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention