BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3771053 · Received December 18, 2013

    Report

    Report Number
    3003288808-2013-00827
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 23, 2013
    Report Date
    November 23, 2013
    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

    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

    AN OPTOMETRIST REPORTED THAT ONE WEEK FOLLOWING BILATERAL LASIK PROCEDURE, THE PT WAS EXPERIENCING DRY EYE IN THE RIGHT EYE, MAINLY IN THE MORNING. THE PT ALSO PRESENTED WITH TRACE MICRO-STRIAE IN THE FAR PERIPHERY OF THE RIGHT EYE, WHICH DID NOT APPEAR TO BE AFFECTING HER VISION. THE PT WAS TREATED WITH INCREASED ARTIFICIAL TEAR DROPS DURING THE DAY, AND WITH GEL AT BEDTIME. THE SYMPTOMS IMPROVED WITH THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664350 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention INTRALASE