BEUDAMED
    FDA Adverse Event Other Summary report: N

    LENSAR LASER SYSTEM -FS 3D

    MDR report key: 3772357 · Received March 6, 2014

    Report

    Report Number
    3009026057-2014-00002
    Event Type
    Other
    Date Received
    March 6, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 6, 2014
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PATIENT SURGERY FILES REVEALS AN ASYMMETRIC DOCK AS EVIDENCED BY A DECENTERED SUCTION RING ON DOWN THE PIPE IMAGE CAPTURES. SIGNIFICANT EYE MOVEMENT IS NOTED PERIODICALLY BEFORE AND DURING COMPLETION OF THE ANTERIOR CAPSULOTOMY AND THROUGHOUT THE REST OF THE PROCEDURE. THIS MOVEMENT IS LIKEWISE EVIDENCED THROUGH THE DISPLACEMENT OF CAPSULOTOMY CYLINDERS ON SEQUENTIAL IMAGE FRAMES. BUBBLE BREAKTHROUGH IS EXTREMELY ASYMMETRIC AND BUBBLE DENSITY IS GREATER IN THE SUPERIOR QUADRANT OF THE FRAME (NASALLY) COMPARED TO THE INFERIOR QUADRANT (TEMPORALLY). THESE MULTIPLE CAPSULOTOMY RINGS APPLIED UNDER THE ANTERIOR CAPSULE LIKELY WEAKENED THE RADIAL STRENGTH OF THE CAPSULAR RIM, WHICH WAS FURTHER COMPOUNDED BY THE PATIENT MOVEMENT DURING THE BREAKTHROUGH OF THE ANTERIOR CAPSULOTOMY ITSELF. AN ANTERIOR RADIAL TEAR COULD POTENTIALLY OCCUR IN THIS SCENARIO AS A RESULT OF INHERENT RADIAL FORCES EXERTED UPON THE ANTERIOR CAPSULAR RIM BY THE SURROUNDING OCULAR APPARATUS.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CLINICAL APPLICATION SPECIALIST (CAS) ON (B)(6) 2014 THAT HE COMPLETED LASER TREATMENT 100% ON A PATIENT. DURING CAPSULOTOMY BUTTON REMOVAL UNDER MICROSCOPE, HE NOTICED A RADIAL TEAR. HE STATED THAT HE PROCEEDED ON WITH CAUTION AND THE REMAINDER OF SURGERY WENT WELL. NO VITRECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136882 LENSAR LASER SYSTEM -FS 3D LENSAR LASER SYSTEM -FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other