BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3819983 · Received May 14, 2014

    Report

    Report Number
    3003288808-2014-00853
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    March 31, 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 Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON COMPANY ACCEPTANCE CRITERIA. 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 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED A PT WITH 3+ PUNCTATE EPITHELIAL KERATITIS (PEK) IN THE RIGHT EYE, TWO DAYS FOLLOWING LASIK TREATMENT, IN THE BAND FROM "3-9 O'CLOCK" ACROSS FLAP, MARGIN TO MARGIN. THE PT REPORTED THE RIGHT EYE WAS DRY AND UNCOMFORTABLE WITH A LITTLE BLUR. IN A F/U WITH A TECH, SHE INDICATED THE PT WAS TOLD TO USE HIS TOPICAL STEROID DROPS EVERY TWO HRS ON THE DATE OF THE EVENT ( (B)(6) 2014) AND THEN RETURN TO NORMAL POSTOP SCHEDULE. THE PT DID NOT SHOW FOR HIS TWO WEEK POSTOP APPOINTMENT BUT WAS SEEN ON (B)(6) 2014 AND THE EVENT HAD RESOLVED. PT REPORTED VISION WAS MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288895 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYS LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention INTRALASE: