BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4173971 · Received October 1, 2014

    Report

    Report Number
    3003288808-2014-01469
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT DURING A PROGRAMMED HYPEROPIA PROCEDURE WITH A LASER SYSTEM, HE COULD ONLY FIRE A FEW SHOTS AND THEN THE TREATMENT STOPPED. THERE WAS NO SYSTEM MESSAGE DISPLAYED. A ONE (1) SECOND TREATMENT WAS PERFORMED. AS THE TREATMENT WAS TOO SHORT, THE OPTICIAN PROGRAMMED THE LASER SYSTEM AGAIN WITH A DIFFERENT PUPIL SIZE OF 4.6 INSTEAD OF 4.5. A SYSTEM MESSAGE WAS DISPLAYED AND IT WAS ACCEPTED. WHEN IMPORTING THE TREATMENT DATA, IT STOPPED AT 75% OF THE DATA TRANSFER. THE RETREATMENT COULD NOT BE PERFORMED AND THE SURGERY WAS POSTPONED TO THE FOLLOWING WEEK (DATE UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611648 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other