BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3675236 · Received February 28, 2014

    Report

    Report Number
    3003288808-2014-00321
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CENTER DIRECTOR REPORTED PT WITH SUB EPITHELIAL INFILTRATES (SEI), UNK ETIOLOGY OF THE RIGHT EYE AT PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. ADD'L DETAILS INDICATED PATIENT ALSO COMPLAINS OF PAIN AND DISCOMFORT AT VISIT. ADD'L INFO INDICATED THE PATIENT WAS FIRST MANAGED WITH ANTIBIOTICS THEN STEROIDS ADDED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123700 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention