BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3761062 · Received April 10, 2014

    Report

    Report Number
    3003288808-2014-00639
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 15, 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

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. ADD'L INFO HAS BEEN REQUESTED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED PT WITH ROUGH FLAP EDGE AND LOOSE EPITHELIUM OF THE RIGHT EYE FOLLOWING AN ENHANCEMENT AND FLAP LIFT AT FOUR DAY LASIK POST-OPERATIVE VISIT. PT WITH COMPLAINTS OF "BURNING, TEARING, AND DISCOMFORT OF THE RIGHT EYE SINCE ENHANCEMENT." ADD'L INFO FROM OPTOMETRIST INDICATED PT WAS SEEN AND INSTRUCTED TO USE A HYPERTONICITY AGENT, HOWEVER PT DID NOT COMPLY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216371 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention INTRALASE