BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q EXCIMER LASER

    MDR report key: 4894540 · Received July 7, 2015

    Report

    Report Number
    3003288808-2015-05833
    Event Type
    Injury
    Date Received
    July 7, 2015
    Date of Event
    February 19, 2015
    Report Date
    July 7, 2015
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE SHOWED THAT THE LASER WAS SUCCESSFULLY VERIFIED PRIOR TO AND AFTER THE DATE OF THE TREATMENT. THE LOGFILE REVIEW FOR THE DATE OF TREATMENT SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS DURING THE TREATMENT DAY. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PATIENT PRESENTED WITH LIGHT SENSITIVITY IN BOTH EYES APPROXIMATELY THREE WEEKS POST LASIK. THE PATIENT WAS NOTED TO HAVE TRANSIENT LIGHT SENSITIVITY (TLS) AND THE PREVIOUSLY PRESCRIBED TOPICAL STEROID EYE DROPS WERE INCREASED. THE PATIENT WAS SEEN IN FOLLOW UP AND WAS NOTED TO HAVE AN INCREASE IN INTRAOCULAR PRESSURE. THE TOPICAL STEROID EYE DROP WAS DISCONTINUED. THE OPTOMETRIST RE-PRESCRIBED THE STEROID AT A LATER DATE AND AGAIN THE PATIENT HAD AN INCREASE IN INTRAOCULAR PRESSURE. THE PATIENT'S CARE HAS BEEN TRANSFERRED TO ANOTHER OPHTHALMOLOGIST. ADDITIONAL INFORMATION PROVIDED STATES THAT THE PATIENT IS DOING BETTER AND VISION IS GOOD. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441489 ALLEGRETTO WAVE EYE-Q EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention