BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED SYSTEM

    MDR report key: 3122039 · Received May 16, 2013

    Report

    Report Number
    3003288808-2013-00261
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IDENTITY OF DEVICE IS BEING SOUGHT. : ONCE INFORMATION BECOMES AVAILABLE, INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS WOULD BE PROGRESSED. 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

    AN OPTOMETRIST REPORTED A CASE OF 'SUSPECT CORNEA ECTASIA', NOTED 6 YEARS POST BILATERAL LASIK PROCEDURE. REPORTER STATED THAT THE PATIENT HAS BEEN REFERRED TO ANOTHER PHYSICIAN FOR FURTHER EVALUATION AND CONFIRMATION OF DIAGNOSIS. REPORT RECEIVED NOTED THAT THE PATIENT EXPRESSED DRYNESS, BILATERALLY, AND DECREASED VISION AT DISTANCE AND NEAR. PATIENT MENTIONED HAVING GONE BACK TO OCCASIONAL WEAR OF CONTACTS AND GLASSES, AND THAT HE WAS INTERESTED IN AN ENHANCEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT REFERENCES THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217330 UNSPECIFIED SYSTEM UNSPECIFIED SYSTEM LZS WAVELIGHT GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other