BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 16103195 · Received January 5, 2023

    Report

    Report Number
    2210968-2023-00097
    Event Type
    Injury
    Date Received
    January 5, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ONLINELIBRARY.WILEY.COM/DOI/ABS/10.1111/J.1755-3768.2022.125.

    Description of Event or Problem · 0

    TITLE: SCLERAL FIXATION OF INTRAOCULAR LENSES USING MERSILENESUTURE. THE PURPOSE OF THIS STUDY IS TO REPORT THE OUTCOMES OF THE SCLERAL FIXATION OF INTRAOCULAR LENS USING MERSILENE SUTURE TECHNIQUE IN THE ABSENCE OF ADEQUATE CAPSULAR BAG SUPPORT. A TOTAL OF 10 PATIENTS (12 EYES) UNDERWENT SCLERAL FIXATION OF BAUSCH AND LOMB AKREOS AO60 IOL USING MERSILENE SUTURE 5-0. THE FOLLOWING EVENT CANNOT BE RULED OUT AS COMPLAINTS. (N=3 EYES) POST-OPERATIVE HYPOTONY (N=2 EYES) CONJUNCTIVAL INFLAMMATION AND EROSION DUE TO AN UNBURIED KNOT AFTER ONE MONTH. IN CONCLUSION, SCLERAL FIXATION OF AKREOS AO60 IOL WITH MERSILENE SUTURE IS A SAFE, ECONOMICAL AND WELL TOLERATED PROCEDURE LEADING TO IMPROVEMENT OF VISUAL ACUITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189311 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention