BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3842794 · Received May 16, 2014

    Report

    Report Number
    3003288808-2014-00877
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 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
    TX, 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 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED FOREIGN BODIES UNDER LEFT EYE FLAP AT ONE DAY LASIK FOLLOW UP. AT VISIT PATIENT COMPLAINED OF "SLIGHT PAIN". ADDITIONAL INFORMATION FROM REPORTER INDICATED PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED AND PATIENT WAS REFERRED TO SURGEON FOR FLAP RINSE AND LIFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293601 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention INTRALASE