BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2932235 · Received January 25, 2013

    Report

    Report Number
    3003288808-2013-00023
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    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. A REVIEW OF THE TECHNICAL SERVICE ON-SITE SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. LASER WAS SUCCESSFULLY VERIFIED PRIOR TO, AND AFTER THE DAY OF THE EVENT. LOGFILE REVIEW FOR THE DATE OF EVENT SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO REPORTED EVENT. THE TREATMENTS WERE COMPLETED TO 100%, WITHOUT INTERRUPTIONS OR ERROR MESSAGES. A ROOT CAUSE, FOR THE REPORTED EVENT, COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT COMPLAINED OF PHOTOPHOBIA AND BURNING EYES. THIS WAS NOTED AT TWO WEEKS POST BILATERAL LASIK SURGERY. PT NOTED INCREASED BURNING WITH THE USE OF "BLINK PF AND GEL TEARS". NOTED SYMPTOMS WERE REPORTED TO HAVE BEEN EXPERIENCED FOR FIVE DAYS, AFTER SURGERY, AND PT ALSO EXPRESSED HAVING A HISTORY OF HYPERSENSITIVITY TO CONTACT LENS SOLUTIONS. PT WAS TREATED WITH CORTICOSTEROID DROPS, FOR POST TREATMENT PHOTOPHOBIA. UPON FOLLOW UP, REPORTER STATED THAT AFTER SWITCHING ARTIFICIAL TEARS, THE PT'S COMPLAINT OF PHOTOPHOBIA AND BURNING SENSATION HAVE RESOLVED, WITH NO IMPACT TO THE PT. THIS REPORT REFERENCES THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36126 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention BLINK PF| GEL TEARS| INTRALASE