BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3954730 · Received July 18, 2014

    Report

    Report Number
    3003288808-2014-01132
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 22, 2014
    Report Date
    June 19, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE. LOGFILES REVIEW SHOWS THAT ALL TREATMENTS WERE COMPLETED TO 100 PERCENT AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. THE SYSTEM HISTORY SHOWS THAT THE LASER WAS VERIFIED SUCCESSFULLY PRIOR AND AFTER THE DATE OF TREATMENT. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE SYSTEM WAS FOUND TO BE WITHIN SPECIFICATIONS. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CENTER DIRECTOR REPORTED A PT WITH EPITHELIAL INGROWTH OF THE LEFT EYE AT LASIK POST-OPERATIVE VISIT. ADDITIONAL INFORMATION INDICATED A FLAP LIFT AND RINSE WAS PERFORMED AND THE REPORTED EVENT RESOLVED AFTER SEVEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422472 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention INTRALASE