BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5114666 · Received September 30, 2015

    Report

    Report Number
    3009026057-2015-00035
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 30, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PATIENT FILES SHOWED THAT THE PATIENT HAD A DENSE CATARACT AND THE SYSTEM WAS ABLE TO PROPERLY IDENTIFY THE CORNEAL AND ANTERIOR LENS SURFACES. THIS IS EXPECTED DUE TO THE LENS DENSITY. THE PROCEDURE FILES SHOWED A CAPSULOTOMY STARTING ON FRAME 3 AND A SIMULTANEOUS BREAKTHROUGH OF THE CAPSULOTOMY AS WELL. THIS IS INDICATIVE OF TREATMENT BEING DELIVERED TO ANTERIOR. R&D WAS CONSULTED AND DETERMINED THAT THERE WAS NO CLEAR CAUSE FOR THE CAPSULOTOMY BEING DELIVERED ANTERIOR TO INTENDED LOCATION. IT IS POSSIBLE THAT THE PATIENT PULLED AWAY FROM THE SYSTEM, BUT THIS COULD NOT BE CONFIRMED. LASER SYSTEM LOG FILES WERE REVIEWED AND NO INDICATION OF DEVICE MALFUNCTION WAS FOUND. NO VITRECTOMY WAS PERFORMED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT THE PATIENT WAS 20/30 AT HIS ONE DAY POST-OP. AND THE PATIENT DID NOT SHOW FOR THE (B)(6) 2015 SCHEDULED FOLLOW UP VISIT. ROOT CAUSE: UNKNOWN

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PATIENT FILES SHOWED THAT THE PATIENT HAD A DENSE CATARACT AND THE SYSTEM WAS ABLE TO PROPERLY IDENTIFY THE CORNEAL AND ANTERIOR LENS SURFACES. THIS IS EXPECTED DUE TO THE LENS DENSITY. THE PROCEDURE FILES SHOWED A CAPSULOTOMY STARTING ON FRAME 3 AND A SIMULTANEOUS BREAKTHROUGH OF THE CAPSULOTOMY AS WELL. THIS IS INDICATIVE OF TREATMENT BEING DELIVERED TO ANTERIOR. R&D WAS CONSULTED AND DETERMINED THAT THERE WAS NO CLEAR CAUSE FOR THE CAPSULOTOMY BEING DELIVERED ANTERIOR TO INTENDED LOCATION. IT IS POSSIBLE THAT THE PATIENT PULLED AWAY FROM THE SYSTEM, BUT THIS COULD NOT BE CONFIRMED. LASER SYSTEM LOG FILES WERE REVIEWED AND NO INDICATION OF DEVICE MALFUNCTION WAS FOUND. NO VITRECTOMY WAS PERFORMED. DURING A POST-OPERATIVE CLINICAL FOLLOW UP THE DOCTOR REPORTED THAT THE PATIENT WAS 20/30 AT HIS ONE DAY POST-OP. AND THE PATIENT DID NOT SHOW FOR THE (B)(6)2015 SCHEDULED FOLLOW UP VISIT. ROOT CAUSE: UNKNOWN.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CAS ON (B)(6) 2015 THAT HE HAD A WHITE CATARACT ON A YOUNG PATIENT AND HE COMPLETED CAPSULOTOMY ONLY. THE DOCTOR REPORTED THE FOLLOWING DETAILS: TRYPAN BLUE IN THE EYE ID'D THE INCOMPLETE CAPSULOTOMY WITH MULTIPLE TAGS AND THE EQUATORIAL CAPSULAR TEARS. HE COMPLETED THE CAPSULOTOMY WITH FORCEPS. THE CATARACT WAS SO SOFT HE WAS ABLE TO GENTLY ASPIRATE IT WITH I/A (NO PHACO NECESSARY). THERE WAS NO WRAPAROUND OF THE CAPSULAR TEARS. HE PLACED A THREE-PIECE Z9002 PCIOL IN THE CAPSULE WITH THE HAPTICS ORIENTED PERPENDICULAR TO THE RADIAL EXTENSIONS. THE LENS CENTERED NICELY AND DID NOT MOVE WITH GENTLE EYE "JOSTLING" (DONE BY THE SURGEON). THE PATIENT WAS 20/30 AT HIS 1 DAY PO THE NEXT DAY. HE NO SHOWED TO HIS ONE WEEK FOLLOW-UP. NEXT SCHEDULED VISIT IS ON (B)(6). SURGEON COMPLETED THE LENSAR PROCEDURE AND WHEN HE PUT TRYPAN BLUE IN THE EYE, THE INCOMPLETE CAPSULOTOMY WITH TAGS AND CAPSULAR TEARS WERE NOTICED.

    Description of Event or Problem · 1

    DOCTOR REPORTED TO A LENSAR CAS ON (B)(6)2015 THAT HE HAD A WHITE CATARACT ON A YOUNG PATIENT AND HE COMPLETED CAPSULOTOMY ONLY. THE DOCTOR REPORTED THE FOLLOWING DETAILS: TRYPAN BLUE IN THE EYE ID'D THE INCOMPLETE CAPSULOTOMY WITH MULTIPLE TAGS AND THE EQUATORIAL CAPSULAR TEARS. HE COMPLETED THE CAPSULOTOMY WITH FORCEPS. THE CATARACT WAS SO SOFT HE WAS ABLE TO GENTLY ASPIRATE IT WITH I/A (NO PHACO NECESSARY). THERE WAS NO WRAPAROUND OF THE CAPSULAR TEARS. HE PLACED A THREE-PIECE Z9002 PCIOL IN THE CAPSULE WITH THE HAPTICS ORIENTED PERPENDICULAR TO THE RADIAL EXTENSIONS. THE LENS CENTERED NICELY AND DID NOT MOVE WITH GENTLE EYE "JOSTLING" (DONE BY THE SURGEON). THE PATIENT WAS 20/30 AT HIS 1 DAY PO THE NEXT DAY. HE NO SHOWED TO HIS ONE WEEK FOLLOWUP. NEXT SCHEDULED VISIT IS ON (B)(6)2016. SURGEON COMPLETED THE LENSAR PROCEDURE AND WHEN HE PUT TRYPAN BLUE IN THE EYE, THE INCOMPLETE CAPSULOTOMY WITH TAGS AND CAPSULAR TEARS WERE NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646477 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 Other