BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7360190 · Received March 21, 2018

    Report

    Report Number
    3006695864-2018-00558
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    February 20, 2018
    Report Date
    April 22, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    HNO
    UDI-DI
    05050474573451
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 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 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. 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 TRANSIENT LIGHT SENSITIVITY (TLS) IN THE RIGHT EYE (OD) AT THE 2 MONTH POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD THE PRIMARY LASER TREATMENT ON (B)(6) 2017 AND THEN UNDERWENT AN ENHANCEMENT TREATMENT ON THE LEFT EYE ON (B)(6) 2017. AT THE 2-MONTH POST OP EXAM FROM THE ENHANCEMENT PROCEDURE, THE PATIENT PRESENTED WITH LIGHT SENSITIVITY IN THE OD. THE SURGERY CENTER REPORTED THE UNCORRECTED VISUAL ACUITY (UCVA) WAS CONSISTENT WITH MONO VISION (MV). THE EVALUATION SHOWS NO ANTERIOR CHAMBER REACTION OR TRACE OF CONJUNCTIVAL INJECTION. THE PATIENT REQUIRES SUNGLASSES INDOORS. TOPICAL STEROIDS WERE INCREASED TO TREAT THE SYMPTOMS. THE PATIENT WAS TREATED WITH PRED FORTE TO BE TAPERED OFF. THE PATIENT¿S COMMENTS WERE OF RIGHT EYE IS MORE SENSITIVE THAN THE LEFT EYE RECENTLY. BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2017: RIGHT EYE PRE-OP 20/20 1.00 X -.50 X 164, LEFT EYE PRE-OP 20/20 .50 X -.50 X 120. BCVA FROM (B)(6) 2017: RIGHT EYE POST-OP 20/20 1.00 X -.50 X 164, LEFT EYE POST-OP 20/20 .75 X -.50 X 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201419 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20005D 05050474573451

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention