BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFS ADVANCED FEMTOSEC LASER

    MDR report key: 11143741 · Received January 9, 2021

    Report

    Report Number
    3006695864-2021-07038
    Event Type
    Injury
    Date Received
    January 9, 2021
    Date of Event
    December 12, 2020
    Report Date
    January 8, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    05050474573468
    PMA / PMN Number
    K141852
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEALTH EFFECT - CLINICAL CODE - 4581 (SLIPPED FLAP), HEALTH EFFECT - CLINICAL CODE - 4581 (STRIAE). A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LASER VISION CORRECTION PATIENT HAD SURGERY ON (B)(6) 2020 AND PRESENTED ON (B)(6) 2020 WITH SLIPPED FLAP WHICH OCCURRED WITH DROPS AND ALSO FLAP WRINKLED AND VISUAL ACUITY DECREASED (VS) IN THE LEFT EYE (OS), POST TREATMENT. A FLAP LIFT AND SMOOTH WAS PERFORMED. IT WAS STATED THAT THE PATIENT HAD NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). THE PATIENT HAD NO QUESTIONS, COMMENTS OR CONCERNS. PATIENT REPORTED SYMPTOMS ARE NOT INTERFERING WITH DAILY ACTIVITIES. BCVA FROM (B)(6) 2020. RIGHT EYE PRE-OP 20/15 -2.00 X -.50 X 145, LEFT EYE PRE-OP 20/15 -2.25 X -.25 X 40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40536 IFS ADVANCED FEMTOSEC LASER POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC J20007D 05050474573468

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR