BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 5004140 · Received August 26, 2015

    Report

    Report Number
    3009026057-2015-00028
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 26, 2015
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, IT WAS DETERMINED THAT IF IMPORTED PATIENT PLANS ARE NOT EDITED AT THE TIME OF IMPORTATION, THE PLAN WILL HAVE THE STARTING CCI LOCATION BASED ON THE LAST EDITED EYE POSITION EITHER OS OR OD. FOR EYES THAT MATCH THE LAST EDITED EYE POSITION, THE STARTING CCI POSITIONS ARE CORRECT, FOR EYES THAT HAVE THE OPPOSITE POSITION, THE STARTING POSITION WILL REFLECT THAT OF THE OPPOSITE EYE AND MAY REQUIRE ADJUSTMENT FROM THE USER.

    Description of Event or Problem · 1

    IF AN IMPORTED PATIENT DOES NOT HAVE THEIR PATIENT PLAN EDITED AFTER IMPORT THE DEFAULT STARTING LOCATION OF ANY CCIS MAY HAVE THE VALUES FOR THE OPPOSITE EYE. THERE HAVE BEEN NO REPORTS OF THE CCI BEING PLACED IN THE INCORRECT LOCATION DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566455 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other