BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3834615 · Received May 2, 2014

    Report

    Report Number
    3003288808-2014-00769
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 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 FIELD 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 LIGHT SENSITIVITY, DRYNESS AND DISCOMFORT IN BOTH EYES ONE WEEK FOLLOWING LASIK TREATMENT. THE PATIENT REPORTED THAT IT WAS "HARD TO OPEN EYES" DUE TO DISCOMFORT. THE PATIENT ALSO REPORTED A "LITTLE RELIEF" FROM USING ARTIFICIAL TEARS BUT ADMITTED SHE WAS "NOT USING THEM AS OFTEN IN THE LAST COUPLE OF DAYS." THE PATIENT WAS PRESCRIBED CYCLOSPORINE OPHTHALMIC EMULSION TWICE A DAY AND FLUOROMETHOLONE OPHTHALMIC SUSPENSION THREE TIMES A DAY FOR 1 WEEK, THEN TWICE A DAY FOR ONE WEEK, AND THEN ONCE A DAY FOR ONE WEEK. IN A FOLLOW UP WITH THE OPTOMETRIST, SHE INDICATED THE PATIENT WAS SEEN ON (B)(6) 2014 AND NO LONGER HAD SYMPTOMS OF LIGHT SENSITIVITY. THE PATIENT REPORTED SOME DISCOMFORT WHILE WORKING ON THE COMPUTER BUT OVERALL WAS FEELING BETTER. THE PATIENT CONTINUED USING THE FLUOROMETHOLONE OPHTHALMIC SUSPENSION ONCE A DAY, CYCLOSPORINE OPHTHALMIC EMULSION TWICE A DAY AND ARTIFICIAL TEARS AS NEEDED. THE OPTOMETRIST ALSO REPORTED THERE WERE NO OBVIOUS REASONS THE PATIENT WAS NOT CORRECTABLE TO 20/20 PRIOR TO SURGERY. THERE ARE TWO 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
    264058 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention INTRALASE