BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7005235 · Received November 6, 2017

    Report

    Report Number
    3006695864-2017-01041
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    January 20, 2017
    Report Date
    December 6, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER'S PHONE NUMBER: (B)(6). (B)(4). A FIELD SERVICE SPECIALIST (FSE) VISITED THE ACCOUNT ON JANUARY 2017 AND REPLACED THE GALVO BLOCK AND PERFORMED MAINTENANCE TO THE SYSTEM. DEVICE WAS COMPLIANT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    IN THE INITIAL REPORT IT WAS REPORTED THAT THE MANUFACTURING DATE FOR THE SYSTEM WAS 10/21/2015. HOWEVER, THE MANUFACTURING SITE HAS NOW PROVIDED THE DATE AS JANUARY 2008. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NO SIGNIFICANT CHANGE OVER HISTORICAL COMPLAINT LIMITS AND NO RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THERE WAS NO PRODUCT DEFICIENCY IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2017 AND THE FLAP BED WAS CORRECTLY DONE BUT THE SIDE CUT WAS GIVING DIFFICULTY WHEN ATTEMPTING TO RAISE THE FLAP. IT WAS SAID THAT THE SIDE CUTS DIDN¿T PREVENT THE PROCEDURE FROM BEING COMPLETED BUT IT WAS DIFFICULT TO PENETRATE THE INTERFACE. ONCE IN, THE STROMAL BED DIDN¿T POSE ANY DISSECTION PROBLEM. ON (B)(6) 2017 THE SURGEON REPORTED THAT THE PATIENT IS REPORTING INDUCED ASTIGMATISM AND VISUAL DISTURBANCES. ON (B)(6) 2017 SURGEON REPORTED THAT THE CUTS FROM THAT SURGERY DATE ((B)(6) 2017) WERE DIFFICULT THAN USUAL BUT ACHIEVABLE, NO COMPLICATIONS IN THE MANUAL PROCEDURE, NORMAL SUCTION, NORMAL CUTTING TIME. NO SHARP INSTRUMENT WAS USED TO PASS THE SIDECUT. THE INSTRUMENT USED HAD A BLUNT EDGE. ON (B)(6) 2017 SURGEON REPORTED THAT PATIENT VISUAL ACUITY IS AS FOLLOWS PRE-OP VISUAL ACUITY: RIGHT EYE 10/10, LEFT EYE 10/10. POST-OP VISUAL ACUITY: RIGHT EYE 8/10, LEFT EYE 7/10. PATIENT INDUCED ASTIGMATISM IS OF MORE THAN 2 DIOPTERS AND GLARE AND BLURRY VISION ARE AFFECTING HER SPECIALLY IN NIGHT VISION. SURGEON REPORTED PATIENT COMPLAINED THAT A FEW WEEKS POST SURGERY, THE PATIENT WENT TO A CAR RALLY (AS CO-DRIVER) AND HAD GREAT DIFFICULTY READING NOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783547 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003K

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other