BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3834598 · Received May 2, 2014

    Report

    Report Number
    3003288808-2014-00767
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 2, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P0300008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT WITH SUDDEN INCREASE IN PHOTOSENSITIVITY IN BOTH EYES, TWO WEEKS FOLLOWING LASIK TREATMENT. THE PATIENT WAS DIAGNOSED WITH TRANSIENT LIGHT SENSITIVITY SYNDROME AND STARTED TOPICAL STEROID GEL FOUR TIMES A DAY FOR SEVEN DAYS IN BOTH EYES AND THEN TAPERED. THE PATIENT REPORTED SHE WAS EXTREMELY LIGHT SENSITIVE AND WAS WEARING TWO AIRS OF SUNGLASSES OUTDOORS AND ONE PAIR INDOORS ALL THE TIME. THE COMPUTER AND CELL PHONE SCREEN BRIGHTNESS HURT HER EYES. IN A FOLLOW UP WITH THE OPTOMETRIST, SHE INDICATED THE PATIENT WAS SEEN ON (B)(6) 2014 AND THE SYMPTOMS HAD RESOLVED. THE PATIENT WAS CONTINUING TO TAPER OFF OF THE TOPICAL STEROID GEL. THERE ARE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264757 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention INTRALASE