BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3082499 · Received April 25, 2013

    Report

    Report Number
    3003288808-2013-00196
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 4, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    UNKNOWN

    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. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED PT HAD LASIK SURGERY, RIGHT EYE ON (B)(6) 2013. A NOMOGRAM WAS USED FOR THE PROCEDURE. ON POST OP VISIT, OVERCORRECTION WAS NOTED. THE PT WILL REQUIRE A RE-TREATMENT IN THE FUTURE. DATE OF THE RE-TREATMENT CAN NOT BE DETERMINED AT THIS TIME. NO FURTHER INFO IS EXPECTED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179825 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other