BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5075493 · Received September 14, 2015

    Report

    Report Number
    3009026057-2015-00032
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 14, 2015
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF PROCEDURE (B)(6): IN REVIEWING THE PATIENT DATA FOR PROCEDURE (B)(6) IT WAS NOTED AN INCOMPLETE CAPSULOTOMY IN THIS CASE. IT APPEARED AT THE 10 O'CLOCK POSITION AND WILL PRESENT ITSELF AS AN ADHESION/INCOMPLETE CAPSULOTOMY TO THE PHYSICIAN. A REVIEW OF THE CLEAR FIELD IMAGES AND ALL DTP IMAGES SHOWED A FIBER OR HAIR EXTENDING INTO THE PUPIL BUT AREN'T IN THE CORRECT LOCATION AS TO HAVE CONTRIBUTED EVENT. SCANNED IMAGES WERE REVIEWED AND NOTED THE FOLLOWING: SCAN (B)(6) SHOWED A PATIENT ANOMALY ON THE SURFACE OF THE ANTERIOR LENS. SCAN (B)(6) SHOWED SOME STRUCTURE ON THE SURFACE OF THE ANTERIOR LENS AT THE APPROXIMATE DIAMETER, 4.75 MM, OF THE CAPSULOTOMY THAT WAS BEING PERFORMED. SCAN (B)(6) SHOWED THE SAME STRUCTURE FROM AN ORTHOGONAL PERSPECTIVE. THIS STRUCTURE COULD SCATTER THE SLD ENERGY IT WILL SCATTER THE LASER ENERGY ULTIMATELY DECREASING THE EFFICIENCY OF THE PHOTO-DISRUPTION. INVESTIGATION OF PROCEDURE (B)(6): PATIENT DATA FOR PROCEDURE (B)(6) WAS REVIEWED AND FOUND NO INDICATIONS THAT THERE WERE ISSUES WITH AN INCOMPLETE CAPSULOTOMY OR ANY ADHESIONS. THE CAPSULOTOMY BEGAN TO BREAK THROUGH ON FRAME 6 AND IS COMPLETE BETWEEN FRAMES 7 AND FRAMES 8. THIS IS EXACTLY WHERE WE WOULD EXPECT TO BREAK INTO THE ANTERIOR CHAMBER. THE BUBBLE FORMATION IS CONTINUOUS AND PREVALENT AROUND THE ENTIRE CAPSULOTOMY. A REVIEW OF THE VIDEO THAT WAS SENT WAS PERFORMED AND UNFORTUNATELY, THE VIDEO STARTED AFTER THE BUTTON WAS REMOVED SO IT MAKES IT IMPOSSIBLE TO DETERMINE THE LOCATION OF ANY ADHESION AND THE ABILITY TO WORK BACKWARDS TO DETERMINE THE PHYSICAL LOCATION AND RELATIVE POSITION TO THE LENSAR SYSTEM. THERE ARE NO INDICATORS IN REVIEWING THE PATIENT DATA THAT WOULD SUGGEST THERE WOULD HAVE BEEN ANY ISSUES WITH THE CAPSULOTOMY DURING THE PHACO PORTION OF THE SURGERY FOR THIS PATIENT. PROCEDURE (B)(6): PATIENT ID (B)(6): ROOT CAUSE: STRUCTURE/DEBRIS IN ANTERIOR CHAMBER LEADING TO INCOMPLETE CAPSULOTOMY. PROCEDURE (B)(6): PATIENT ID (B)(6): ROOT CAUSE: UNKNOWN - UNKNOWN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF PROCEDURE 6240 IN REVIEWING THE PATIENT DATA FOR PROCEDURE 6240 IT WAS NOTED AN INCOMPLETE CAPSULOTOMY IN THIS CASE. IT APPEARED AT THE 10 O'CLOCK POSITION AND WILL PRESENT ITSELF AS AN ADHESION/INCOMPLETE CAPSULOTOMY TO THE PHYSICIAN. A REVIEW OF THE CLEAR FIELD IMAGES AND ALL DTP IMAGES SHOWED A FIBER OR HAIR EXTENDING INTO THE PUPIL BUT AREN'T IN THE CORRECT LOCATION AS TO HAVE CONTRIBUTED EVENT. SCANNED IMAGES WERE REVIEWED AND NOTED THE FOLLOWING: SCAN 0000 AND 0005 SHOWED A PATIENT ANOMALY ON THE SURFACE OF THE ANTERIOR LENS. SCAN 0000 SHOWED SOME STRUCTURE ON THE SURFACE OF THE ANTERIOR LENS AT THE APPROXIMATE DIAMETER, 4.75 MM, OF THE CAPSULOTOMY THAT WAS BEING PERFORMED. SCAN 0005 SHOWED THE SAME STRUCTURE FROM AN ORTHOGONAL PERSPECTIVE. THIS STRUCTURE COULD SCATTER THE SLD ENERGY IT WILL SCATTER THE LASER ENERGY ULTIMATELY DECREASING THE EFFICIENCY OF THE PHOTO-DISRUPTION. INVESTIGATION OF PROCEDURE 6295 PATIENT DATA FOR PROCEDURE 6295 WAS REVIEWED AND FOUND NO INDICATIONS THAT THERE WERE ISSUES WITH AN INCOMPLETE CAPSULOTOMY OR ANY ADHESIONS. THE CAPSULOTOMY BEGAN TO BREAK THROUGH ON FRAME 6 AND IS COMPLETE BETWEEN FRAMES 7 AND FRAMES 8. THIS IS EXACTLY WHERE WE WOULD EXPECT TO BREAK INTO THE ANTERIOR CHAMBER. THE BUBBLE FORMATION IS CONTINUOUS AND PREVALENT AROUND THE ENTIRE CAPSULOTOMY. A REVIEW OF THE VIDEO THAT WAS SENT WAS PERFORMED AND UNFORTUNATELY, THE VIDEO STARTED AFTER THE BUTTON WAS REMOVED SO IT MAKES IT IMPOSSIBLE TO DETERMINE THE LOCATION OF ANY ADHESION AND THE ABILITY TO WORK BACKWARDS TO DETERMINE THE PHYSICAL LOCATION AND RELATIVE POSITION TO THE LENSAR SYSTEM. THERE ARE NO INDICATORS IN REVIEWING THE PATIENT DATA THAT WOULD SUGGEST THERE WOULD HAVE BEEN ANY ISSUES WITH THE CAPSULOTOMY DURING THE PHACO PORTION OF THE SURGERY FOR THIS PATIENT. PROCEDURE 6240 PATIENT ID (B)(6). ROOT CAUSE: STRUCTURE/DEBRIS IN ANTERIOR CHAMBER LEADING TO INCOMPLETE CAPSULOTOMY PROCEDURE 6295 PATIENT ID (B)(6). ROOT CAUSE: UNKNOWN - UNKNOWN

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR CAS IN AN EMAIL DATED (B)(6) 2015 THAT HE WAS HAVING PROBLEMS WITH CCC. THE DOCTOR HAD 5 BROKEN CAPSULE, FOUR OF THEM WERE DUE TO THE FEMTO ANTERIOR EDGE. TODAY'S CATARACT WAS DENSE AND IT DEFAULTED TO SECONDARY PATTERN WITH RING AND CROSS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO A LENSAR CAS IN AN EMAIL DATED (B)(6)2015 THAT HE WAS HAVING PROBLEMS WITH CCC. THE DOCTOR HAD 5 BROKEN CAPSULE, FOUR OF THEM WERE DUE TO THE FEMTO ANTERIOR EDGE. TODAY'S CATARACT WAS DENSE AND IT DEFAULTED TO SECONDARY PATTERN WITH RING AND CROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607872 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other