BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5067005 · Received September 10, 2015

    Report

    Report Number
    3009026057-2015-00031
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    August 12, 2015
    Report Date
    September 9, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SURGICAL IMAGES WERE EVALUATED AND NOTED THAT THE CAPSULOTOMY BEGAN TO BREAK INTO THE ANTERIOR CHAMBER ON FRAME 6 AND FINISHED ON FRAME 7. THE LASER WAS FIRING AT THE CORRECT Z LOCATION. FURTHER REVIEW OF THE SURGICAL IMAGES BETWEEN FRAMES 21 AND 42, DO SHOW THE DEVELOPMENT AND PROPAGATION OF GAS ALONG THE POSTERIOR OF THE CAPSULAR BAG BETWEEN THE 10 O'CLOCK AND 3 O'CLOCK POSITION. THE DOCTOR DESCRIBED THE CHAMBER APPEARING DEEPER TEMPORALLY WHICH WOULD BE CONSISTENT WITH THE LARGEST GAS BUILD UP. THE GAS ACCUMULATION COUPLED WITH THE FAIRLY SIGNIFICANT DENSE POSTERIOR CATARACT COULD HAVE MADE FOR A DIFFICULT LENS EXTRACTION WITHOUT STRESSING THE CAPSULAR BAG. THERE ARE NO INDICATIONS THAT THE LASER FIRED AND IMPACTED THE POSTERIOR CAPSULAR BAG, HOWEVER, THE PROXIMITY OF THE POSTERIOR CATARACT AND THE INCREASED STRESS FROM ADDITIONAL GAS BUILD UP COULD HAVE CONTRIBUTED TO ISSUES WITH THE POSTERIOR CAPSULE WHEN ATTEMPTING TO REMOVE THE LENS.

    Additional Manufacturer Narrative · 1

    THE PATIENT SURGICAL IMAGES WERE EVALUATED AND NOTED THAT THE CAPSULOTOMY BEGAN TO BREAK INTO THE ANTERIOR CHAMBER ON FRAME 6 AND FINISHED ON FRAME 7. THE LASER WAS FIRING AT THE CORRECT Z LOCATION. FURTHER REVIEW OF THE SURGICAL IMAGES BETWEEN FRAMES 21 AND 42, DO SHOW THE DEVELOPMENT AND PROPAGATION OF GAS ALONG THE POSTERIOR OF THE CAPSULAR BAG BETWEEN THE 10 O'CLOCK AND 3 O'CLOCK POSITION. THE DOCTOR DESCRIBED THE CHAMBER APPEARING DEEPER TEMPORALLY WHICH WOULD BE CONSISTENT WITH THE LARGEST GAS BUILD UP. THE GAS ACCUMULATION COUPLED WITH THE FAIRLY SIGNIFICANT DENSE POSTERIOR CATARACT COULD HAVE MADE FOR A DIFFICULT LENS EXTRACTION WITHOUT STRESSING THE CAPSULAR BAG. THERE ARE NO INDICATIONS THAT THE LASER FIRED AND IMPACTED THE POSTERIOR CAPSULAR BAG, HOWEVER, THE PROXIMITY OF THE POSTERIOR CATARACT AND THE INCREASED STRESS FROM ADDITIONAL GAS BUILD UP COULD HAVE CONTRIBUTED TO ISSUES WITH THE POSTERIOR CAPSULE WHEN ATTEMPTING TO REMOVE THE LENS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A DISTRIBUTOR REPRESENTATIVE ON (B)(6) 2015 THAT HAD A CAPSULE TEAR ON A PATIENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO A DISTRIBUTOR REPRESENTATIVE ON (B)(6)2015 THAT HAD A CAPSULE TEAR ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601202 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