BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18873856 · Received March 11, 2024

    Report

    Report Number
    2210968-2024-02796
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    January 1, 2023
    Report Date
    March 11, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. CITATION: HTTPS://DOI.ORG/10.1016/J.YAOO.2023.02.005.

    Description of Event or Problem · 0

    TITLE: CORRECTION OF PEDIATRIC APHAKIA THE OBJECTIVE OF THIS STUDY IS TO DISCUSS THE VARIOUS TREATMENT OPTIONS AVAILABLE FOR CORRECTING PEDIATRIC APHAKIA, INCLUDING THE USE OF SPECTACLES, CONTACT LENSES, AND IOLS. IN A RETROSPECTIVE CASE SERIES OF 33 EYES OF 26 CHILDREN UNDERGOING SCLERAL FIXATION OF AN IOL, THE USE OF 10-0 POLYPROPYLENE RESULTED IN SUTURE BREAKAGE OCCURRING AT A MEAN OF 5.11 YEARS AFTER SURGERY (3.5¿9 YEARS) IN CHILDREN. IN A RETROSPECTIVE STUDY OF INTRASCLERAL HAPTIC FIXATION IN 40 EYES OF 25 CHILDREN WITH ECTOPIA LENTIS, PATIENTS WERE FOLLOWED FOR A MEDIAN OF 12 MONTHS (12¿62 MONTHS). TYPICALLY, POLYPROPYLENE (PROLENE-ETHICON INC, RARITAN, NJ) OR POLYTETRAFLUOROETHYLENE (GORE-TEX¿GORE MEDICAL, NEWARK, DE) SUTURES ARE USED. IN HAPTIC FIXATION, THE HAPTICS OF THE IOL PASSES THROUGH THE SCLERAL WALL AND MAINTAIN CENTRATION OF THE OPTIC. THREE-PIECE IOLS ARE USED THAT HAVE HAPTICS MADE OF POLYMETHYLMETHACRYLATE (PMMA) OR POLYVINYLIDENE FLUORIDE (PVDF). THE USE OF POLYPROPYLENE ALLOWS FOR FIXATION THROUGH THE CONJUNCTIVA WITHOUT PERFORMING A CONJUNCTIVAL PERITOMY. ONCE THE SUTURE IS PASSED THROUGH THE CONJUNCTIVA AND SCLERA, THE IOL CAN BE FIXATED WITH THE ENDS OF THE SUTURE FASHIONED INTO BULBS USING LOW-TEMPERATURE CAUTERY AND BURIED INTO THE SCLERA TO PREVENT OVERLYING CONJUNCTIVAL EROSION. INTRASCLERAL HAPTIC FIXATION IS ADVANTAGEOUS IN THAT IT AVOIDS THE CONCERNS OF SUTURE MATERIAL FOR IOL FIXATION AND GENERALLY IS A QUICKER SURGERY. REPORTED COMPLICATIONS INCLUDE SUTURE BREAKAGE (N=?), IOL SUBLUXATION (N=1), AND INTRAOCULAR HEMORRHAGE (N=5). IN CONCLUSION, PEDIATRIC APHAKIA CAN PRESENT DIFFICULTIES IN MANAGEMENT, AS IT IS FREQUENTLY ASSOCIATED WITH OTHER OCULAR COMORBIDITIES, SUCH AS GLAUCOMA, AMBLYOPIA, AND STRUCTURAL DEFECTS OF THE EYE REQUIRING CREATIVE TECHNIQUES FOR IOL FIXATION. EACH PATIENT PRESENTS UNIQUE CHALLENGES, AND AN UNDERSTANDING OF THE TREATMENT MODALITIES OUTLINED IN THIS ARTICLE ALLOWS FOR CUSTOMIZED CARE OF PEDIATRIC APHAKIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160889 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention