BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4173969 · Received October 1, 2014

    Report

    Report Number
    3003288808-2014-01473
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE COMPANY'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT WITH A CORNEAL ABRASION IN THE RIGHT EYE AT THE SIX DAYS POST (PRK) PHOTOREFRACTIVE KERATECTOMY VISIT. A BANDAGE CONTACT LENS WAS PLACED DUE TO PATIENT PAIN; LIGHT SENSITIVITY AND SWELLING. THE PATIENT WILL CONTINUE THE POST OPERATIVE DROPS, ANTIBIOTIC, STEROID AND PRESERVATIVE FREE ARTIFICIAL TEARS. THE REPORTED ABRASION HAS HEALED. THE PATIENT HAS STOPPED ALL DROPS EXCEPT ARTIFICIAL TEARS AS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610694 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention