BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5067006 · Received September 10, 2015

    Report

    Report Number
    3009026057-2015-00030
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 13, 2015
    Report Date
    September 9, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION IT WAS DETERMINED THAT IF AN IMPORTED PATIENT DOES NOT HAVE THEIR PATIENT PLAN EDITED IMMEDIATELY AFTER IMPORT THE SURGEON'S DEFAULT STARTING LOCATION FOR THE CCI OR BLADE MASK MAY BE PRESENTED IN AN UNINTENDED LOCATION. UPON INVESTIGATION, IT WAS DETERMINED THAT IF PATIENT DATA IS IMPORTED FROM THE CORNEAL ANALYZER AND THOSE FILES ARE NOT EDITED AT THE TIME OF IMPORTATION, THE CCI OR BLADE MASK POSITION IS INITIALLY BASED ON THE CCI POSITION USED FOR THE EYE (EITHER OS OR OD) IN THE LAST PATIENT DATA FILE THAT WAS EDITED. WHEN THE LAST EDITED EYE (EITHER OS OR OD) MATCHES THE EYE ORIENTATION (EITHER OS OR OD) OF A NON-EDITED PATIENT DATA FILE THE CCI OR BLADE MASK WILL BE IN THE CORRECT DEFAULT POSITION. WHEN THE LAST EDITED EYE (EITHER OS OR OD) IS OPPOSITE TO THE EYE ORIENTATION (EITHER OS OR OD) OF A NON-EDITED PATIENT DATA FILE THE CCI OR BLADE MASK WILL BE IN AN INCORRECT POSITION AND WILL LIKELY REQUIRE THE USER TO ADJUST THE CCI OR BLADE MASK LOCATION. A QUALITY BULLETIN HAS BEEN GENERATED AND SENT OUT TO THE LENSAR USERS AND THE SOFTWARE APPLICATION WAS UPDATED.

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION IT WAS DETERMINED THAT IF AN IMPORTED PATIENT DOES NOT HAVE THEIR PATIENT PLAN EDITED IMMEDIATELY AFTER IMPORT THE SURGEON'S DEFAULT STARTING LOCATION FOR THE CCI OR BLADE MASK MAY BE PRESENTED IN AN UNINTENDED LOCATION. UPON INVESTIGATION, IT WAS DETERMINED THAT IF PATIENT DATA IS IMPORTED FROM THE CORNEAL ANALYZER AND THOSE FILES ARE NOT EDITED AT THE TIME OF IMPORTATION, THE CCI OR BLADE MASK POSITION IS INITIALLY BASED ON THE CCI POSITION USED FOR THE EYE (EITHER OS OR OD) IN THE LAST PATIENT DATA FILE THAT WAS EDITED. WHEN THE LAST EDITED EYE (EITHER OS OR OD) MATCHES THE EYE ORIENTATION (EITHER OS OR OD) OF A NON-EDITED PATIENT DATA FILE THE CCI OR BLADE MASK WILL BE IN THE CORRECT DEFAULT POSITION. WHEN THE LAST EDITED EYE (EITHER OS OR OD) IS OPPOSITE TO THE EYE ORIENTATION (EITHER OS OR OD) OF A NON-EDITED PATIENT DATA FILE THE CCI OR BLADE MASK WILL BE IN AN INCORRECT POSITION AND WILL LIKELY REQUIRE THE USER TO ADJUST THE CCI OR BLADE MASK LOCATION. A QUALITY BULLETIN HAS BEEN GENERATED AND SENT OUT TO THE LENSAR USERS AND THE SOFTWARE APPLICATION WAS UPDATED.

    Description of Event or Problem · 1

    A LENSAR CAS REPORTED ON (B)(6) 2015 THAT WHILE ON SITE FOR SURGERY SUPPORT SHE OBSERVED THAT THE CCI WAS POPULATING NASALLY. THIS CAN POTENTIALLY OCCUR ON CASSINI IMPORT CASES WHICH WERE NOT EDITED PRIOR TO CLOSING THE PENDING PATIENTS DIALOG.

    Description of Event or Problem · 1

    A LENSAR CAS REPORTED ON 08/14/15 THAT WHILE ON SITE FOR SURGERY SUPPORT SHE OBSERVED THAT THE CCI WAS POPULATING NASALLY. THIS CAN POTENTTIALLY OCCUR ON CASSINI IMPORT CASES WHICH WERE NOT EDITED PRIOR TO CLOSING THE PENDING PATIENTS DIALOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601201 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 64 YR