BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE

    MDR report key: 7607947 · Received June 15, 2018

    Report

    Report Number
    2210968-2018-73521
    Event Type
    Injury
    Date Received
    June 15, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENTS WERE REPORTED THROUGH A JOURNAL ARTICLE AND IT IS UNKNOWN IF THE EVENTS HAVE BEEN PREVIOUSLY REPORTED. NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. REFERENCE ATTACHED JOURNAL ARTICLE

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ENTITLED: INTRAOPERATIVE PERFORMANCE AND POSTOPERATIVE OUTCOMES OF ENDOCAPSULAR RING IMPLANTATION IN PEDIATRIC EYES AUTHORS: VAISHALI VASAVADA, MS, VIRAJ A. VASAVADA, MS, ROBERT O. HOFFMAN, MD, TERRENCE S. SPENCER, MD, RISHI V. KUMAR, MD, ALAN S. CRANDALL, MD. CITATION: J CATARACT REFRACT SURG. 2008; 34: 1499¿1508. THE PURPOSE WAS TO STUDY THE INTRAOPERATIVE PERFORMANCE AND POST-OPERATIVE OUTCOMES OF CIONNI MODIFIED CAPSULE TENSION RING (CTR) AND INTRAOCULAR LENS (IOL). A TOTAL OF 22 PATIENTS (35 EYES; AGE RANGE: 2.5 TO O 18 YEARS OLD) WITH ECTOPIA LENTIS AND VISUALLY SIGNIFICANT CATARACT THAT HAD LENS ASPIRATION AND IN-THE-BAG IMPLANTATION OF SINGLE-PIECE ACRYSOF IOL AND CIONNI CTR WERE INCLUDED. SINGLE- AND DOUBLE-EYELET CTRS WERE USED. DURING THE PROCEDURE, A PROLENE 9-0 OR 10-0 DOUBLE-ARMED SUTURE ON CTC NEEDLES WAS THREADED THROUGH THE FIXATION EYELETS OF THE MODIFIED CTR. THE 2 NEEDLES WERE PASSED INTO THE MAIN INCISION AND THEN OUT THROUGH THE CILIARY SULCUS AND SCLERAL WALL, EXITING BENEATH THE SCLERAL GROOVE. SUBSEQUENTLY, THE CTR WAS INTRODUCED THROUGH THE MAIN INCISION INTO THE CAPSULAR BAG AND DIALED INTO POSITION SO THAT THE FIXATION EYELETS LAY IN THE AREA OF MAXIMUM ZONULAR WEAKNESS, THUS ENSURING THAT THE EYELET OR EYELETS WERE POSITIONED ANTERIOR TO THE CAPSULORHEXIS. THE SUTURES WERE TIGHTENED AND TIED TO CENTER AND STABILIZE THE CAPSULAR BAG. THE MAIN AND PARACENTESIS INCISIONS AND THE CONJUNCTIVA WERE SUTURED WITH VICRYL 10-0 POLYGLACTIN (VICRYL) SUTURES. REPORTED COMPLICATIONS INCLUDED PATIENT 3 (6.2-YEAR-OLD RIGHT EYE; 2.5-YEAR-OLD LEFT EYE) MALE PATIENT WITH PCO AND CHRONIC UVEITIS WHICH REQUIRED PARS PLANA VITRECTOMY ON BOTH EYES. IT WAS CONCLUDED THAT THE IMPLANTATION OF THE CIONNI CTR AND SINGLE-PIECE ACRYSOF IOL IN THE CAPSULAR BAG IN PEDIATRIC EYES WITH SUBLUXATED LENSES WAS SAFE AND EFFECTIVE AND LED TO A STABLE IOL WITH FEW SIGNIFICANT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450356 VICRYL POLYGLACTIN 910 SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention