BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3890763 · Received June 11, 2014

    Report

    Report Number
    3003288808-2014-00967
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 13, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 WAS REVIEWED AND THERE WERE NO UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE AND THE PRODUCT WAS RELEASED ACCORDING TO COMPANY ACCEPTABLE CRITERIA. (B)(4).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE TECHNICAL SERVICE ON-SITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT: LASER WAS SUCCESSFULLY VERIFIED PRIOR AND AFTER THE DAY OF THE TREATMENT. LOGFILE REVIEW FOR THE DATE OF TREATMENT SHOWS NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WER COMPLETED TO 100% AND ALL LASER SYSTEM FUNCTIONS WERE WITHIN SPECIFICATIONS AT THIS DAY. NO TECHNICAL ROOT CAUSE WAS IDENTIFIED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED CORNEAL EROSION OF THE RIGHT EYE AT 3 MONTH PHOTOREFRACTIVE KERATECTOMY (PRK) POST-OPERATIVE VISIT. AT VISIT PATIENT COMPLAINED OF BLURRY VISION. ADDITIONAL INFORMATION FROM REPORTER INDICATED A BANDAGE CONTACT LENS WAS NEEDED TO TREAT THE EVENT AND THE PATIENT'S TOPICAL STEROID DOSAGE WAS INCREASED WHICH HELPED TO RESOLVE THE REPORTED ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345887 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention