BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRALASE FS2

    MDR report key: 7326274 · Received March 9, 2018

    Report

    Report Number
    3006695864-2018-00475
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 8, 2018
    Report Date
    April 11, 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

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

    Additional Manufacturer Narrative · 1

    A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A 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. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. 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 LOOSE EPITHELIUM IN BOTH EYES (OU) ON THE SAME DAY OF LASER TREATMENT. THE SURGERY CENTER PLACED A BANDAGE CONTACT LENS (BCLS) ON BOTH EYES. AT THE ONE-DAY POST OP EXAM, AN EPITHELIAL DEFECT WAS OBSERVED ON THE RIGHT EYE (OD). THE PATIENT'S COMMENTS WAS OF CONCERN REGARDING VISUAL ACUITY. THE SURGERY CENTER PLACED BCLS AGAIN ON OU. AT THE ONE-MONTH POST OP EXAM, THE LOOSE EPITHELIUM AND EPITHELIAL DEFECT WAS STILL PRESENT. THE SURGERY CENTER INDICATED THE PLACEMENT OF THE BCLS WAS OUTSIDE THE NORMAL POST OP REGIMEN. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) FROM (B)(6) 2018: RIGHT EYE (OD) PRE-OP 20/20 1.75 X -1.00 X 98, LEFT EYE (OS) PRE-OP 20/20 2.25 X -.75 X 86.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171192 INTRALASE FS2 FEMTOSECOND LASER HNO JOHNSON & JOHNSON SURGICAL VISION, INC 20003D

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention WAVELIGHT SERIAL NO. (B)(4)