BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2052564 · Received April 8, 2011

    Report

    Report Number
    3003288808-2011-00065
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 11, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/PO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS VERIFIED BY FIELD SERVICE ENGINEER AND FOUND TO BE OPERATING TO SPECIFICATIONS. CASE LOG FILE REVIEW DID NOT SHOW ANY SYSTEM ISSUES. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEVICE WAS FOUND TO BE OPERATING TO SPECIFICATIONS. ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTED POST OPERATIVE CENTRAL ISLANDS AND MYOPIA, POST LASIK SURGERY. PT INFORMATION REC'D SHOWS SLIGHT UNDERCORRECTION AT FIVE WEEKS POST OP, FOR THE LEFT EYE. SURGEON STATED THAT THE CASE MAY NEED AN ADDITIONAL PROCEDURE IN THE FUTURE. RIGHT EYE OF THE SAME PT IS REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other