BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3771025 · Received December 18, 2013

    Report

    Report Number
    3003288808-2013-00855
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 20, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    NOT APPLICABLE

    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 CONSUMER REPORTED THAT FOLLOWING LASIK SURGERY, HE HAD BLURRY VISION "ALTERNATIVELY" IN THE RIGHT EYE AND THE LEFT EYE BLURS AT TIME. HE ALSO REPORTED HIS HEAD AND EYES HURT WHEN BOTH EYES ARE OPEN AND HE CANNOT USE THE COMPUTER WITHOUT CLOSING THE RIGHT EYE. THE CONSUMER REPORTED, ACCORDING TO TEST PERFORMED PRIOR TO SURGERY, THE RIGHT EYE HAD BETTER VISION AND THAT FOLLOWING SURGERY, THE LEFT EYE HAD BETTER VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663938 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other