BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3255680 · Received July 24, 2013

    Report

    Report Number
    3003288808-2013-00437
    Event Type
    Injury
    Date Received
    July 24, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 TECH REPORTED A CASE OF AN UNDERCORRECTION AFTER BILATERAL LASIK. THE PT HAD VERY LARGE PUPILS AND THE SURGEON CHOSE TO USE A 7.0 OPTICAL ZONE (OZ) AS OPPOSED TO THE STANDARD 6.5 (OZ). THIS REPORT REFERENCES THE LEFT EYE. ANOTHER REPORT WILL BE FILED FOR THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344955 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other