BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4240309 · Received October 29, 2014

    Report

    Report Number
    3003288808-2014-01589
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE CRITERIA. 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. (B)(4).

    Description of Event or Problem · 1

    A CENTER DIRECTOR REPORTED A PATIENT WITH TRANSIENT LIGHT SENSITIVITY SYNDROME (TLSS) A THREE MONTH LASIK POST-OPERATIVE VISIT. AT VISIT PATIENT COMPLAINED OF PHOTOSENSITIVITY. ADDITIONAL INFORMATION FROM REPORTER INDICTED PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT IS FOR THE RIGHT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691252 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INTRALASE