BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3122036 · Received May 16, 2013

    Report

    Report Number
    3003288808-2013-00258
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    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

    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 A PATIENT APPEARED TO E HYPERACCOMODATING IN BOTH EYES FOLLOWING BILATERAL LASIK SURGERY. THE REPORTER BELIEVES THAT THERE WAS NO MISTREATMENT AND THAT THE POST-OP K READINGS ARE AS EXPECTED GIVEN THE PRE-OP PRESCRIPTION, AND THE TREATMENT DATA IS CORRECT. A CLAPIKS (CONTACT LENS ASSISTED PHARMACOLOGICAL INDUCED STEEPENING) TRIAL OF CONTACT LENSES AND STEROID EYE DROPS TO ASSIST WITH HEALING. THIS REPORT CONCERNS THE PATIENT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217066 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INTRALASE