BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 8023743 · Received October 31, 2018

    Report

    Report Number
    3009026057-2018-00007
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    October 5, 2018
    Report Date
    October 30, 2018
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    UDI-DI
    00867744000112
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SURGICAL IMAGES WERE REVIEWED AND FOUND THE IRIS REGISTRATION FAILED AND A MESSAGE WAS DISPLAYED TO THE DOCTOR. IN ADDITION, IT WAS FOUND THE ICL WAS NOT REMOVED BEFORE THE SURGICAL PROCEDURE. THE ICL CHANGED THE LASER FOCUS POSTERIORLY APPROXIMATELY 1.0 MM. THE LAST SURGICAL FRAME THAT CAPTURES THE COMPLETION OF THE CAPSULOTOMY, FRAME 9, SHOWED THAT THE CAPSULOTOMY WAS PERFORMED IN THE LENS. THE ICL PUSHED THE LASER TREATMENT POSTERIORLY. THE DOCTOR PERFORMED A VITRECTOMY, THE IOL WILL BE CHANGED TO A C LOOP TYPE. HAVING AN ICL IMPLANTED WOULD BE A CONTRAINDICATION FOR SURGERY.

    Description of Event or Problem · 0

    ON 10/05/2018, LENSAR REPRESENTATIVE REPORTED THAT THE DOCTOR HAD A PROCEDURE IN WHICH THE CAPSULOTOMY WAS MADE IN THE MIDDLE OF THE LENS AND THE CHOP ABLATED ON THE POSTERIOR LENS. ACCORDING TO THE SURGEON, THE PATIENT HAD ICL (STAAR) IN HIS EYE AND THE SURGEON REMOVED ICL FROM HIS EYE TO DO A CATARACT SURGERY. ACCORDING TO THE CLINICAL APPLICATION STAFF, THE SCAN PROCEDURE WAS SUCCESSFUL AND IRIS REGISTRATION FAILED. NO MESSAGE WAS SHOWED DURING THE SURGERY.

    Additional Manufacturer Narrative · 1

    SURGICAL IMAGES WERE REVIEWED AND FOUND THE IRIS REGISTRATION FAILED AND A MESSAGE WAS DISPLAYED TO THE DOCTOR. IN ADDITION, IT WAS FOUND THE ICL WAS NOT REMOVED BEFORE THE SURGICAL PROCEDURE. THE ICL CHANGED THE LASER FOCUS POSTERIORLY APPROXIMATELY 1.0 MM. THE LAST SURGICAL FRAME THAT CAPTURES THE COMPLETION OF THE CAPSULOTOMY, FRAME 9, SHOWED THAT THE CAPSULOTOMY WAS PERFORMED IN THE LENS. THE ICL PUSHED THE LASER TREATMENT POSTERIORLY. THE DOCTOR PERFORMED A VITRECTOMY, THE IOL WILL BE CHANGED TO A C LOOP TYPE. HAVING AN ICL IMPLANTED WOULD BE A CONTRAINDICATION FOR SURGERY.

    Description of Event or Problem · 1

    ON (B)(6) 2018, LENSAR REPRESENTATIVE REPORTED THAT THE DOCTOR HAD A PROCEDURE IN WHICH THE CAPSULOTOMY WAS MADE IN THE MIDDLE OF THE LENS AND THE CHOP ABLATED ON THE POSTERIOR LENS. ACCORDING TO THE SURGEON, THE PATIENT HAD ICL(STAAR) IN HIS EYE AND THE SURGEON REMOVED ICL FROM HIS EYE TO DO A CATARACT SURGERY. ACCORDING TO THE CLINICAL APPLICATION STAFF, THE SCAN PROCEDURE WAS SUCCESSFUL AND IRIS REGISTRATION FAILED. NO MESSAGE WAS SHOWED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867179 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC N/A N/A 00867744000112

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other