BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5540868 · Received April 1, 2016

    Report

    Report Number
    3009026057-2016-00012
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    March 4, 2016
    Report Date
    April 5, 2016
    Manufacturer
    LENSAR, LLC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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.

    Additional Manufacturer Narrative · 1

    FROM THE INVESTIGATION WE DETERMINED THE USER DID NOT SELECT COMPUTE AXIS FROM (B)(4) SOFTWARE. BECAUSE OF THIS, THE USER WAS REQUIRED TO INPUT THE AXIS LOCATION WHERE THEY WANT THE INTELLI AXIS MARKS TO BE LOCATED. CLINICAL APPLICATIONS COMMUNICATED WITH THE DOCTOR AND THE OPTION IS NOW SELECTED AT THE SITE. DURING A POST-OPERATIVE CLINICAL FOLLOW THE DOCTOR REPORTED THAT THE IOL WAS ROTATED AND NO ADDITIONAL TREATMENT WAS NECESSARY. ROOT CAUSE: USER ERROR.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST THAT THE SYSTEM MADE THE INTELLIAXIS MARKS ON THE WRONG AXIS FOR 2 DIFFERENT PATIENTS.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST THAT THE SYSTEM MADE THE INTELLIAXIS MARKS ON THE WRONG AXIS FOR 2 DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197829 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, LLC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other