BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7325308 · Received March 8, 2018

    Report

    Report Number
    3006695864-2018-00467
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 9, 2018
    Report Date
    April 9, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    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

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

    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.

    Description of Event or Problem · 1

    THE SURGERY CENTER REPORTED THAT A LASER VISION CORRECTION PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATITIS (DLK) IN BOTH EYES (OU) AT THE 1-DAY POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD TRACE DLK IN THE RIGHT EYE (OD) AND DLK STAGE 1+ IN THE LEFT EYE (OS). THE PATIENT¿S CHIEF COMPLAINT WAS OF DISCOMFORT MORE ON THE OS THAN THE OD. TOPICAL STEROID DOSAGE WAS INCREASED TO RESOLVE SYMPTOMS. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/20 -2.50 X -1.50 X 111, LEFT EYE PRE-OP 20/20 -3.75 X -.75 X 75. THIS REPORT IS FOR THE FEMTO LASER. A SEPARATE REPORT WILL BE SUBMITTED FOR THE EXCIMER LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167375 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention