BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7376503 · Received March 28, 2018

    Report

    Report Number
    3006695864-2018-00606
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 19, 2018
    Report Date
    May 28, 2018
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN THE LEFT EYE (OS) AT THE 2-DAY POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED IT WAS A VERY SLIGHT DLK AND PRED-GATI (PREDNISOLONE ACETATE AND GATIFLOXACIN) WAS INCREASED RATHER THAN STEROID USE ALONE. THE CORNEA BECAME EDEMATOUS. THE SURGERY CENTER DISCONTINUED THE PRED GATI REGIMEN AND THE PATIENT IS MUCH BETTER. THE SURGERY CENTER INDICATED THE PATIENT HAD A LIKELY ALLERGIC REACTION TO THE GATIFLOXACIN PRESCRIBED. THE SURGERY CENTER REPORTED THE PATIENT EXPERIENCED A LOSS OF BEST CORRECTED VISUAL ACUITY. THE PATIENT¿S CHIEF COMPLAINT WAS OF SLIGHTLY BLURRED VISION. AT A 10-DAY POST OP EXAM, THE PATIENT COMMENTED ON DOING MUCH BETTER AND IS ON PRED FORTE ARTIFICIAL TEARS SUBSTITUTIONS ONLY (AN INCREASE IN TOPICAL STEROIDS). THE PATIENT OUTCOME IS EXPECTED WELL. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -7.25 X -1.00 X 25, LEFT EYE PRE-OP 20/20 -6.75 X -1.00 X 148. BCVA FROM (B)(6) 2018: RIGHT EYE POST-OP 20/25, LEFT EYE POST-OP 20/40. 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
    222496 INTRALASE FS2 FEMTOSECOND LASER HNO ABBOTT MEDICAL OPTICS 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention EXCIMER LASER SERIAL NO. (B)(4)