BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5067003 · Received September 10, 2015

    Report

    Report Number
    3009026057-2015-00029
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 11, 2015
    Report Date
    September 9, 2015
    Manufacturer
    LENSAR, INC
    Product Code
    HQC
    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

    TREATMENT FILES WERE REVIEWED AND FROM THE ONSET OF THE PROCEDURE THE PATIENTS EYE WAS MOVING. IT WAS VERY CLEAR THAT THE PID WAS NOT PROPERLY LOCKED. MOVEMENT OCCURRED THROUGHOUT THE PROCEDURE AND TOWARD THE END OF THE FRAGMENTATION TREATMENT A LARGE AIR BUBBLE MOVE INTO THE TREATMENT AREA CAUSED BY THE PATIENT MOVEMENT AND DOWNWARD SHIFT OF THE SUCTION RING FROM THE PID. THE SURGEON DID NOT STOP THE TREATMENT AND AS THE BUBBLE PASSED INTO THE TREATMENT PATTERN A CORNEAL ETCH OCCURRED. THE LASER SYSTEM LOG FILES WERE REVIEWED AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    TREATMENT FILES WERE REVIEWED AND FROM THE ONSET OF THE PROCEDURE THE PATIENTS EYE WAS MOVING. IT WAS VERY CLEAR THAT THE PID WAS NOT PROPERLY LOCKED. MOVEMENT OCCURRED THROUGHOUT THE PROCEDURE AND TOWARD THE END OF THE FRAGMENTATION TREATMENT A LARGE AIR BUBBLE MOVE INTO THE TREATMENT AREA CAUSED BY THE PATIENT MOVEMENT AND DOWNWARD SHIFT OF THE SUCTION RING FROM THE PID. THE SURGEON DID NOT STOP THE TREATMENT AND AS THE BUBBLE PASSED INTO THE TREATMENT PATTERN A CORNEAL ETCH OCCURRED. THE LASER SYSTEM LOG FILES WERE REVIEWED AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A CUSTOMER REPORTED TO A LENSAR DISTRIBUTOR FSE THAT DURING A PROCEDURE THE SUCTION RING LOOKED LIKE IT WAS LOCKED INTO THE PATIENT INTERFACE DEVICE, BUT DURING THE PROCEDURE THE PATIENT MOVED AND APPARENTLY THE SUCTION RING WAS NOT FULLY LOCKED INTO THE PID AND THE LASER SKIPPED THE AK. THE PROCEDURE AND THE CAPSULOTOMY ONLY COMPLETED 2/3 OF THE WAY. THE DOCTOR SAID THAT THE FRAGMENTATION LOOKED GOOD, BUT HE SAID IT LOOKED LIKE THERE WAS SOME SCUFFING OF THE AK. THE PATIENT' CORNEA WAS ETCHED.

    Description of Event or Problem · 1

    ON (B)(4)15 A CUSTOMER REPORTED TO A LENSAR DISTRIBUTOR FSE THAT DURING A PROCEDURE THE SUCTION RING LOOKED LIKE IT WAS LOCKED INTO THE PATIENT INTERFACE DEVICE, BUT DURING THE PROCEDURE THE PATIENT MOVED AND APPARENTLY THE SUCTION RING WAS NOT FULLY LOCKED INTO THE PID AND THE LASER SKIPPED THE AK. THE PROCEDURE AND THE CAPSULOTOMY ONLY COMPLETED 2/3 OF THE WAY. THE DOCTOR SAID THAT THE FRAGMENTATION LOOKED GOOD, BUT HE SAID IT LOOKED LIKE THERE WAS SOME SCUFFING OF THE AK. THE PATIENT' CORNEA WAS ETCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601200 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D HQC LENSAR, INC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other