BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 6448537 · Received March 30, 2017

    Report

    Report Number
    3006695864-2017-00197
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    January 28, 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

    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 8/18/2017 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.

    Additional Manufacturer Narrative · 1

    (B)(4). NO PATIENT CODE AVAILABLE FOR LOOSE EPITHELIUM. 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 RIGHT EYE (OD) AFTER THE SAME DAY OF TREATMENT. THE PATIENT COMPLAINED OF BLURRY VISION. THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY. A BANDAGE CONTACT LENSES (BCL) WAS PLACED ON THE EYE. THE SURGERY CENTER INDICATED THE PATIENT HAD SUBCLINICAL ANTERIOR BASEMENT MEMBRANE DYSTROPHY (ABMD) AND NOT RELATED TO THE LASER. FOLLOW UP REVEALED THE LOOSE EPITHELIUM HAD NOT BEEN RESOLVED ON ITS OWN, AND THE RIGHT EYE WAS DEBRIDED TO RESOLVE SYMPTOMS. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2013. LEFT EYE (OS) PRE-OP 20/20 -1.25 X -.75 X 11. POST-OP BCVA FROM (B)(6) 2017. RIGHT EYE (OD) POST-OP 20/20 1.50 X -.25 X 30. LEFT EYE (OS) POST-OP 20/20 -.50 X .00 X 90. POST-OP BCVA FROM (B)(6) 2017, RIGHT EYE (OD) POST-OP 20/30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229783 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)