BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3819992 · Received May 14, 2014

    Report

    Report Number
    3003288808-2014-00843
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 26, 2014
    Report Date
    April 15, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE CRITERIA. ADDITIONAL INFO HAS BEEN REQUESTED. 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 PT WITH TWO OR THREE PLUS PUNCTATE EPITHELIAL KERATITIS (PEK) WITH REDUCED TEAR FILM AND TEAR BREAKUP TIME AND DRY EYES AT TWO MONTH LASIK POST-OP VISIT. AT VISIT PT COMPLAINED OF "SOME BLURRINESS AND DRYNESS". ADDITIONAL INFO FROM REPORTED INDICATED PT'S ARTIFICIAL TEARS AND CYCLOSPORINE OPHTHALMIC SOLUTION DOSAGE WERE INCREASED. ADDITIONAL INFO HAS BEEN REQUESTED. THIS REPORT CAPTURES THE LEFT EYE, AND ADDITIONAL REPORT IS FILED FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288898 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INRALASE