BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4132792 · Received September 29, 2014

    Report

    Report Number
    3003288808-2014-01446
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 CUSTOMER REPORTED A PATIENT WITH LIGHT SENSITIVITY, DRYNESS AND BLURRED VISION AT THE ONE WEEK POST LASIK VISIT. THE STEROID DROPS WERE INCREASED AND GEL TEARS WERE ADDED AT BEDTIME. PATIENT ALSO HAD PUNCTAL PLUGS PLACED IN THE LOWER PUNCTUM. THE PATIENT REPORTED DRYNESS, LIGHT SENSITIVITY AND BLURRED VISION HAS ALL IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT REFERENCES THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606952 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention INTRALASE