BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3214036 · Received July 3, 2013

    Report

    Report Number
    3003288808-2013-00399
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 6, 2013
    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. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT WITH CHRONIC PHOTOPHOBIA IN BOTH EYES APPROXIMATELY TWO MONTHS FOLLOWING LASIK TREATMENT. THE OPTOMETRIST QUESTIONS WHETHER IT IS TRANSIENT LIGHT SENSITIVITY SYNDROME (TLS) OR IF THE PHOTOPHOBIA IS SECONDARY TO CHRONIC DRY EYE. FOLLOW-UP WITH A TECHNICIAN INDICATED THE PATIENT'S SYMPTOMS ARE RESOLVING. ON A SCALE FROM 1 TO 10 HER INITIAL SYMPTOMS WERE RATED AS 9 AND AT HER LAST VISIT THE PATIENT RATED HER SYMPTOMS AS 2. THE PATIENT DISCONTINUED STEROID DROPS AND IS NOT SCHEDULED TO RETURN UNTIL HER ANNUAL EXAMINATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305165 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention INTRALASE