BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3082506 · Received April 25, 2013

    Report

    Report Number
    3003288808-2013-00191
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    March 16, 2013
    Report Date
    April 4, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    UNKNOWN

    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A PT HAD BILATERAL LASIK SURGERY ON (B)(6) 2013. ON POST OP VISIT BILATERAL OVERCORRECTION WAS NOTED. A NOMOGRAM WAS USED FOR THE PROCEDURE. THE PT WILL REQUIRE A RE-TREATMENT IN THE FUTURE. DATE OF THE RE-TREATMENT CANNOT BE DETERMINED AT THIS TIME. NO FURTHER INFO IS EXPECTED FOR THIS CASE. THIS REPORT WILL ADDRESS THE LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178363 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other