BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3022453 · Received March 22, 2013

    Report

    Report Number
    3003288808-2013-00118
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 20, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THAT AFTER BILATERAL LASIK SURGERY, PATIENT PRESENTED POST OPERATIVE APPOINTMENT WITH DRY EYES, GLARE , AND HALO. OPTOMETRIST ALSO REPORTED DURING REMOVAL OF PUNCTAL PLUG, THE RIGHT LOWER LID PLUG WAS ACCIDENTLY DISLODGED INTO THE PUNCTA. PATIENT WAS PRESCRIBED REWETTING DROPS AND ALPHAGAN TO HELP REDUCE THE GLARES AND HALOS. THIS REPORT REFERENCES THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120382 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention