BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5191525 · Received October 30, 2015

    Report

    Report Number
    3009026057-2015-00043
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 1, 2015
    Report Date
    October 30, 2015
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF AN IMPORTED PATIENT DOES NOT HAVE THEIR PATIENT PLAN EDITED IMMEDIATELY AFTER IMPORT THE DEFAULT STARTING LOCATION FOR THE CCI OR CCI MASK MAY CHANGE TO AN UNINTENDED LOCATION. FOR ANY IMPORTED TREATMENT FILE THAT IS NOT EDITED IMMEDIATELY AFTER IMPORT, THE PLANNED CCI OR THE CCI MASK POSITION WILL INITIALLY BE BASED ON THE CCI POSITION USED FOR THE EYE IN THE LAST PATIENT DATA FILE THAT WAS EDITED. THIS WILL POTENTIALLY GENERATE A CCI OR CCI MASK LOCATION 180 DEGREES FROM INTENDED POSITION IF THE EYE PLANNED FOR TREATMENT IS CONTRALATERAL (OD OR OS) TO THE LAST EYE EDITED. A QUALITY BULLETIN WAS SENT OUT TO LENSAR USERS AND THE SOFTWARE APPLICATION WAS UPDATED.

    Additional Manufacturer Narrative · 1

    IF AN IMPORTED PATIENT DOES NOT HAVE THEIR PATIENT PLAN EDITED IMMEDIATELY AFTER IMPORT THE DEFAULT STARTING LOCATION FOR THE CCI OR CCI MASK MAY CHANGE TO AN UNINTENDED LOCATION. FOR ANY IMPORTED TREATMENT FILE THAT IS NOT EDITED IMMEDIATELY AFTER IMPORT, THE PLANNED CCI OR THE CCI MASK POSITION WILL INITIALLY BE BASED ON THE CCI POSITION USED FOR THE EYE IN THE LAST PATIENT DATA FILE THAT WAS EDITED. THIS WILL POTENTIALLY GENERATE A CCI OR CCI MASK LOCATION 180 DEGREES FROM INTENDED POSITION IF THE EYE PLANNED FOR TREATMENT IS CONTRALATERAL (OD OR OS) TO THE LAST EYE EDITED. A QUALITY BULLETIN WAS SENT OUT TO LENSAR USERS AND THE SOTWARE APPLICATION WAS UPDATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON (B)(6) 2015, THAT THE LENSDOCTOR APPLICATION IS NOT REMEMBERING THE SURGEONS INCISION SIZES. IT ALSO DOESN'T ALWAYS SWITCH FROM 180 TO 0 DEGREES IF YOU GO FROM RIGHT EYE TO LEFT EYE AND VICE VERSA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON (B)(6) 2015, THAT THE LENS DOCTOR APPLICATION IS NOT REMEMBERING THE SURGEONS INCISION SIZES. IT ALSO DOESN'T ALWAYS SWITCH FROM 180 TO 0 DEGREES IF YOU GO FROM RIGHT EYE TO LEFT EYE AND VICE VERSA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723670 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1