BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5402072 · Received February 1, 2016

    Report

    Report Number
    3009026057-2016-00001
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    January 4, 2016
    Report Date
    February 3, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE TREATMENT FILES WAS PERFORMED AND NOTED THAT THE SUCTION RING WAS MILDLY DECENTERED. THE INITIAL SUCTION QUALITY WAS SUB-PAR BASED UPON NO SPECKLE PATTERN OVER 50% OF THE SUCTION RING. FROM ONSET IT WAS NOTICED A MILD FLUID LOSS OCCURRING DURING TREATMENT, THERE WERE SMALL OCULAR MOVEMENTS THROUGHOUT THE PROCEDURE AND ON SLIDE 28-31 YOU SEE A MARKED INCREASE IN EYE MOVEMENT FOLLOWED BY A FULL BREAK IN SUCTION ON FRAME 32. FRAME 33 SHOWS FRAGMENTATION PATTERN DELIVERED INTO THE CORNEA. NO ADDITIONAL SURGICAL INTERVENTION WAS REPORTED INITIALLY BY THE DOCTOR. PES CAS CONTACTED THE OFFICE IN SEVERAL OCCASIONS REQUESTING THE PATIENT-POST OPERATIVE CLINICAL RESULTS, BUT THE DOCTOR'S OFFICE DID NOT PROVIDE THE REQUESTED INFORMATION. ROOT CAUSE: PATIENT MOVED.

    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.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT A SUCTION LOSS OCCURRED AT 66% AND ABORTED. DURING PHACO THE SURGEON NOTICED THAT THE CORNEA HAD BEEN MARKED.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT A SUCTION LOSS OCCURRED AT 66% AND ABORTED. DURING PHACO THE SURGEON NOTICED THAT THE CORNEA HAD BEEN MARKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59624 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