BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LADARVISION

    MDR report key: 1000947 · Received February 20, 2008

    Report

    Report Number
    1061857-2008-00028
    Event Type
    Injury
    Date Received
    February 20, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ALCON -ORLANDO TECHNOLOGY CTR
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THIS REPORT MAILED IN TO FDA ON: 02/20/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED PTS (20 EYES) WITH DIFFUSE LAMELLAR KERATITIS (DLK) FOLLOWING REFRACTIVE SURGERY AND WAS TREATED WITH TOPICAL CORTICOSTEROIDS. ADD'L INFO HAS BEEN REQUESTED. TWENTY EYES REPORTED UNDER MFR #1061857-2008-00021-00040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON -ORLANDO TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Required Intervention