BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 12085960 · Received June 29, 2021

    Report

    Report Number
    3006695864-2021-08002
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 15, 2021
    Report Date
    August 16, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES, RETURNED TO MANUFACTURER ON 07/22/2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES . DEVICE EVALUATION: ONE (1) DEVICE WAS RETURNED WITHIN ITS ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER. A VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT REVEAL ANY DEBRIS, LOOSE PARTICLES, OR FIBERS. THE REPORTED ISSUE COULD NOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT#. ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DEBRIS ON THE CONE OF THE PATIENT INTERFACE THAT WAS BEING USED FOR THE OPERATIVE EYE. CONE HAD PATIENT CONTACT AND PROCEDURE WAS FIRED AND LOST WHILE THE CONE HAD DEBRIS. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION NEEDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979426 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60278656 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 FEMTO SN (B)(6)