BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 13895799 · Received March 24, 2022

    Report

    Report Number
    3012236936-2022-00663
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 24, 2022
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PT. INFO.: UNKNOWN/NOT PROVIDED (B)(4). 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 · 0

    THE ACCOUNT REPORTED SUCTION DID NOT HOLD LEADING TO DECENTERED CUT, PARTIAL FLAP WITH A PATIENT INTERFACE ON THE LEFT (OS) EYE. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA). PATIENT HAS ELECTED TO HAVE PHOTOREFRACTIVE KERATECTOMY (PRK) LATER THIS MONTH. FROM (B)(6) 2022: BCVA OD: DISTANCE 20/ (PRE-OP20/20) OS: DISTANCE 20/ (PRE-OP 20/20).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850702 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60324361 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male FEMTO LASER S/N (B)(4)