BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1872812 · Received October 14, 2010

    Report

    Report Number
    3003288808-2010-00451
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 14, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    A CUSTOMER REPORTS A PATIENT THAT IS OVERCORRECTED IN BOTH EYES FOLLOWING BILATERAL LASIK SURGERY FOR MONOVISION DUE TO HIGH VOLTAGE. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED ON MANUFACTURER REPORT NUMBER 3003288808-2010-00452. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other