BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2960327 · Received February 8, 2013

    Report

    Report Number
    3003288808-2013-00034
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 10, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PT'S DRY EYE SYMPTOMS HAVE WORSENED IN BOTH EYES SINCE HAVING BILATERAL LASIK. THIS REPORT CONCERNS THE PT'S LEFT EYE. THE PT WAS INFORMED PRIOR TO SURGERY THAT HER DRY EYES MAY BE MADE WORSE AFTER LASIK. THE PT HAD BEEN REFERRED TO A CORNEAL SPECIALIST AND IS ON SEVERAL TREATMENTS FROM THAT DOCTOR. THE PT WAS INFORMED THAT DRY EYE SYNDROME IS A CHRONIC CONDITION WHICH MUST BE MANAGED OVER THE LONG TERM, BUT WILL NEVER GO AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54099 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INTRALASE