BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6723047 · Received July 18, 2017

    Report

    Report Number
    3006695864-2017-00510
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    June 23, 2017
    Report Date
    September 11, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE RECORDS RELATED TO THIS EQUIPMENT THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION WAS PERFORMED. THE TREND REVIEW SHOWS THAT THERE IS NOT 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. ADDITIONAL INFORMATION: A CORPORATE REPRESENTATIVE FROM THE ACCOUNT CONTACTED TECHNICAL SUPPORT ON (B)(6) 2017 REPORTING SEVERAL ISSUES OF LOOSE EPITHELIUM FOLLOWING FLAP CREATION. APPLICATIONS SUPPORT MANAGER (ASM) VISITED THE SITE ON (B)(4) 2017 AND OBSERVED 24 EYES WITH NO EPITHELIAL ISSUES. DISCUSSED FLAP LIFT TECHNIQUE WITH SURGEON. GELLED THE SYSTEM AND MADE CHANGES TO BED ENERGY AND SIDE CUT ENERGY TO MAKE FLAP LIFT EASIER. SURGEON WAS PLEASED WITH THESE SETTINGS. TECHNICIAN WAS APPLYING 3-6 DROPS OF PROPARACAINE IN EACH EYE PRIOR TO THE PROCEDURE AND AGREES TO CHANGE AND USE ONE-TWO DROPS PER EYE INSTEAD. PER SURGEON¿S INFO EPITHELIAL ISSUES ARE NOT CONSISTENT AND OCCUR ON YOUNG PATIENTS AND OLDER. SOME HAVE CORNEAL DYSTROPHY THAT WOULD EXPLAIN THE PROBLEM BUT SOME HAVE NO PRE-EXISTING CONDITIONS. HE DOES NOT FEEL THE ISSUE IS CAUSED BY THE INTRALASE BUT FEELS HAVING AN EASIER FLAP LIFT WOULD DECREASE ANY EPITHELIAL DISRUPTION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLINIC IS REPORTING THIS ADVERSE EVENT ONLY AND DID NOT REQUEST OR REQUIRE FIELD SERVICE OR CLINICAL SUPPORT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH LOOSE EPITHELIUM ON BOTH EYES (OU) AFTER THE INITIAL LASER TREATMENT ON THE SAME DAY. BOTH EYES WERE DEBRIDED AND THE EVENT WAS CONSIDERED LASTING AND DISABLING, SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. THE SURGERY CENTER INDICATED IT WAS LIKELY NOT LASER RELATED. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY NOTED AND THE PATIENT HAD NO COMPLAINT OR COMMENTS. PRE-OP; BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6)2017: RIGHT EYE PRE-OP 20/20 -1.25 X -1.00 X 155, LEFT EYE PRE-OP 20/20 -1.25 X -.50 X 42. THIS REPORT IS FOR THE FEMTO LASER EQUIPMENT. A SEPARATE REPORT WILL BE SUBMITTED FOR THE EXCIMER LASER EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504325 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention