BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3040127 · Received April 3, 2013

    Report

    Report Number
    3003288808-2013-00150
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 PRIOR TO A BILATERAL PRK, (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE, THE LASER OPERATOR MISTAKENLY TRANSPOSED THE TREATMENT CYLINDER AXIS BY 100 DEGREES, WHEN ENTERING TREATMENT PARAMETERS INTO THE LASER FOR THE PATIENT'S LEFT EYE. THE LASER OPERATOR HAS BEEN RE-TRAINED BY THE SITE. REPORTER ALSO STATED THAT THE PATIENT EXPERIENCED GHOSTING IN THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136829 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention INTRALASE