BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 12025977 · Received June 18, 2021

    Report

    Report Number
    3006695864-2021-07961
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Date of Event
    August 31, 2020
    Report Date
    July 7, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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 LOOSE PARTICLES/FIBERS ON THE PATIENT INTERFACE THAT WAS BEING USED FOR THE OPERATIVE EYE. THE CUSTOMER DOES NOT KNOW IF THIS WAS DISCOVERED DURING PATIENT CONTACT. 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
    923621 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60094310 15050474534688

    Patients

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