BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1083410 · Received July 17, 2008

    Report

    Report Number
    3003288808-2008-00004
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    January 1, 2007
    Report Date
    June 17, 2008
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DETERMINATION OF ROOT CAUSE: ASSESSMENT: A DEVICE EVAL COULD NOT BE PERFORMED BECAUSE NO INFO RELATING TO DEVIC IDENTIFICATION WAS PROVIDED. THIS PT HAD THE POST-OPERATIVE COMPLICATION OF FLOATERS; HOWEVER, THE ASSOCIATION BETWEEN THE PT'S OUTCOME AND THE DEVICE IS UNK. CONCLUSION: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED.

    Description of Event or Problem · 1

    ALCON RECEIVED A VOLUNTARY MEDWATCH FROM THE FDA, AND UPON FURTHER COMMUNICATION WITH THE FDA, ALCON WAS UNABLE TO OBTAIN ANY ADD'L INFO RELATED TO THE EVENT. PT REPORTS, "AFTER LASIK, I DEVELOPED TERRIBLE FLOATERS THAT INTERFERE WITH MANY ACTIVITIES. IT IS A TERRIBLE EXPERIENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT AG (PRESSATH) UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other