BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT EX500 EXCIMER LASER

    MDR report key: 3851678 · Received April 18, 2014

    Report

    Report Number
    3003288808-2014-00668
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P020050
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE MFR'S ACCEPTANCE CRITERIA. A ROOT CAUSE HAS NOT BEEN IDENTIFIED BASED ON THE INITIAL INVESTIGATION. THE ROOT CAUSE WILL BE RE-ASSESSED UPON COMPLETING THE INVESTIGATION. 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 SURGEON REPORTED THAT LESS THAN ONE MONTH FOLLOWING LASIK, HE HAD THREE PTS WITH UNEXPECTED REFRACTIVE OUTCOME. THE SURGEON INDICATED THAT HE PLANNED ON OBSERVING THESE PTS CLOSELY, AS THEY WERE STILL WITHIN THE HEALING PROCESS. ADDITIONAL INFO HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PT WHO HAD PREVIOUS IMPLANTABLE CONTACT LENS (ICL) IMPLANTATION (PT 3 OF 3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238514 WAVELIGHT EX500 EXCIMER LASER OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990794 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other WAVELIGHT FS 200 FEMTOSECOND LASER