BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5404137 · Received February 2, 2016

    Report

    Report Number
    3009026057-2016-00003
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 19, 2016
    Report Date
    February 2, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT TREATMENT FILE WAS PERFORMED AND NOTED THAT THE EYE WAS WELL CENTERED AND THE PROCEDURE INITIATED WITH NO NOTED ISSUES. FRAME 3 SHOWED THE INITIATION OF CAPSULAR INCISION AND ON FRAME 6 YOU SEE 70% INITIAL BREAKTHROUGH. FULL CAPSULAR BREAKTHROUGH IS SEEN ON FRAME 7. THERE WAS NO NOTED ISSUES WITH THE CAPSULAR INCISION AROUND THE AREA NOTED (10 O'CLOCK) THAT CONTRIBUTED TO THE RADIAL TEAR. NO SURGICAL INTERVENTION WAS PERFORMED. THE LASER LOG FILE WAS REVIEWED AND THE SURGICAL PROCEDURE WAS PERFORMED WITH NO INDICATIONS OF A DEVICE MALFUNCTION. ROOT CAUSE: UNKNOWN

    Additional Manufacturer Narrative · 1

    THE PATIENT TREATMENT FILE WAS PERFORMED AND NOTED THAT THE EYE WAS WELL CENTERED AND THE PROCEDURE INITIATED WITH NO NOTED ISSUES. FRAME 3 SHOWED THE INITIATION OF CAPSULAR INCISION AND ON FRAME 6 YOU SEE 70% INITIAL BREAKTHROUGH. FULL CAPSULAR BREAKTHROUGH IS SEEN ON FRAME 7. THERE WAS NO NOTED ISSUES WITH THE CAPSULAR INCISION AROUND THE AREA NOTED (10 O'CLOCK) THAT CONTRIBUTED TO THE RADIAL TEAR. NO SURGICAL INTERVENTION WAS PERFORMED. THE LASER LOG FILE WAS REVIEWED AND THE SURGICAL PROCEDURE WAS PERFORMED WITH NO INDICATIONS OF A DEVICE MALFUNCTION. ROOT CAUSE: UNKNOWN.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT DURING THE REMOVAL OF CAPSULOTOMY OF A PATIENT HE NOTICED AN ANTERIOR RADIAL TEAR AT 10 O'CLOCK HOUR, WHICH EXTENDED PAST THE ZONULAS.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT DURING THE REMOVAL OF CAPSULOTOMY OF A PATIENT HE NOTICED AN ANTERIOR RADIAL TEAR AT 10 O'CLOCK HOUR, WHICH EXTENDED PAST THE ZONULAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64073 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