BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10800846 · Received November 6, 2020

    Report

    Report Number
    2210968-2020-08762
    Event Type
    Injury
    Date Received
    November 6, 2020
    Date of Event
    October 2, 2018
    Report Date
    October 13, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROLENE SUTURE AND VICRYL SUTURE ) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (VITREOUS CHAMBER BLEEDING, DECENTERED DOWNWARDS LENS, POST-OP IOL DECENTRATION, POST-OP CHRONIC CYSTOID MACULAR OEDEMA, INCREASED POST-OP IOP) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PROLENE SUTURE AND VICRYL SUTURE) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: BMJ OPEN OPHTHALMOLOGY 2018;3:E000174. DOI: DOI:10.1136/BMJOPHTH-2018-000174. EVENTS WERE SUBMITTED VIA 2210968-2020-08763.

    Description of Event or Problem · 1

    TITLE: INTRAOCULAR LENS DISLOCATION: A NOVEL INSITU SCLERAL REFIXATION TECHNIQUE USING A 25 GAUGE TROCAR IN THE ANTERIOR CHAMBER. THIS RETROSPECTIVE NON-COMPARATIVE CONSECUTIVE CASE SERIES STUDY FOCUSES ON THE EFFICACY AND SAFETY OF A IOL CLOSED-EYE REPOSITIONING TECHNIQUE USING SCLERAL SUTURE, WHICH IS PERFORMED USING A TROCAR AS AN INTRASTROMAL LIMBAL GUIDE. BETWEEN JANUARY 2015 AND MAY 2017, 31 EYES OF 31 PATIENTS (AVERAGE AGE OF 75.5 YEARS) WITH LATE IOL DISLOCATION UNDERWENT ANTERIOR VITRECTOMY AND A SCLERAL REFIXATION IN A CLOSED CHAMBER USING A 10/0 POLYPROPYLENE SUTURE PASSED THROUGH A 25 GAUGE TROCAR INSERTED IN THE ANTERIOR CHAMBER. A 10/0 PROLENE (ETHICON) STRAIGHT DOUBLE-ARMED NEEDLE WAS INSERTED AT 10 O¿CLOCK THROUGH THE TROCAR IN THE ANTERIOR CHAMBER, UNDER THE IOL LOOP, DOCKED INSIDE THE 25 G NEEDLE AND FINALLY WAS CONDUCTED THROUGH THE SCLERA AND THEN OUT OF THE EYE. THEN, THE NEEDLE OF THE SECOND PROLENE (ETHICON) ARM WAS CONDUCTED THROUGH THE SAME TROCAR AT 10 O¿CLOCK, AND IT WAS PASSED ABOVE THE LOOP AND THEN OUTSIDE THE EYE DOCKED IN THE SAME NEEDLE WHICH WAS INSERTED AT 2 O¿CLOCK 1 MM ALONGSIDE THE PREVIOUS EXIT IN ORDER TO CREATE TWO SF POINTS. PROLENE SUTURES (ETHICON) WERE TENSIONED AND KNOTTED ON BOTH SIDES IN ORDER TO FIX AND CENTRE THE OIL AND THE EDGES WERE CUT 10 MM LONG AND POSITIONED UNDER THE CONJUNCTIVA AND THE TENON CAPSULE IN ORDER TO AVOID CONJUNCTIVAL SCRATCHING AND LACERATION. THE TROCAR WAS REMOVED AND VICRYL 8/0 (ETHICON) CONJUNCTIVAL SUTURE WAS PERFORMED. INTRAOPERATIVE EVENTS OF ANTERIOR CHAMBER BLEEDING (N=2) AND VITREOUS CHAMBER BLEEDING (N=2) WERE REPORTED. INCREASED POSTOPERATIVE INTRAOCULAR PRESSURE (N=6), LENS WAS FOUND DECENTERED DOWNWARDS (N=1), POSTOPERATIVE IOL DECENTRATION (N=1) THAT CAUSED THE LENS TO MOVE IN ORDER TO HAVE THE EDGE ALONG THE VISUAL AXIS AND THEREFORE THE VISION WAS COMPROMISED AND POSTOPERATIVE CHRONIC CYSTOID MACULAR OEDEMA (CME) (N=2) WERE REPORTED. THE INTRAOPERATIVE ANTERIOR CHAMBER BLEEDING WAS RESOLVED AFTER A VISCOAT INJECTION AND BLOOD ASPIRATION USING THE VITRECTOMY PROBE. THE VITREOUS CHAMBER BLEEDING WAS RESOLVED BY RAISING THE INFUSION PRESSURE TO 50 MM HG FOR 2 MIN AND PPV. THE INCREASED POSTOPERATIVE INTRAOCULAR PRESSURE WAS RESOLVED WITH UNSPECIFIED MEDICAL THERAPY. SECONDARY IRIS FIXATION IOL IMPLANTATION WAS PERFORMED IN THE PATIENT WHO HAD POSTOPERATIVE IOL DECENTRATION. NEPAFENAC EYE DROPS WAS USED TO RESOLVE THE CME. WE CAN AFFIRM THAT OUR TECHNIQUE MAY BE SAFE AND USEFUL IN THE CASE OF 3-PIECE IN-THE BAG OR OUT-OF THE BAG DISLOCATED IOLS AND ALSO IN THE CASE OF IN-THE-BAG SINGLE-PIECE DISLOCATED IOLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265905 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention