BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7380524 · Received March 28, 2018

    Report

    Report Number
    3006695864-2018-00624
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 26, 2018
    Report Date
    May 30, 2018
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    PMA / PMN Number
    K060372
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 A WRINKLE ON BOTH EYES (OU) AT A 2-DAY POST-OPERATIVE EXAM. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THE PATIENT HAD WRINKLES IN THE FLAPS THAT WERE CAUSED BY THE PATIENT¿S SLEEP MASK RIDING UP. A FLAP LIFT AND RINSE WAS PERFORMED TO SMOOTH OUT THE WRINKLES. IN ADDITION, IT WAS INDICATED THE CONTACT LENS (CL) FELL OUT DIRECTLY AFTER THE LIFT AND RINSE TREATMENT AND WHEN RETURNING FOR A REPLACEMENT OF THE CL, THE SURGERY CENTER REALIZED THE WRINKLES HAD APPEARED AGAIN. ANOTHER FLAP LIFT AND RINSE WAS PERFORMED TO SMOOTH OUT THE WRINKLES. THE SURGERY CENTER REPORTED THE PATIENT EXPERIENCED LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE SURGERY CENTER REPORTED THE SYMPTOMS HAVE BEEN RESOLVED. BCVA FROM (B)(6) 2018: RIGHT EYE PRE-OP 20/15 -3.25 X .00 X 90, LEFT EYE PRE-OP 20/15 -3.25 X .00 X 90.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219964 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)