BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 2040517 · Received March 18, 2011

    Report

    Report Number
    3003288808-2011-00053
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    PHYSICIANS REPORT LASIK FLAP THICKNESS INCONSISTENCY, ON MULTIPLE CASES, WHEN COMPARING ENTERED TARGET VALUE TO POST FLAP CREATION MEASUREMENT VALUES. ONE PHYSICIAN REPORTED FLAPS THAT WERE THINNER THAN EXPECTED, AND ANOTHER PHYSICIAN PROVIDED VALUES THAT SHOWED THINNER AND THICKER VALUES. PT OUTCOME INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1