BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18705353 · Received February 14, 2024

    Report

    Report Number
    2210968-2024-01373
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    October 8, 2020
    Report Date
    February 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CLINICAL OPHTHALMOLOGY 2020:14 3131¿3136; HTTP://DOI.ORG/10.2147/OPTH.S276226.

    Description of Event or Problem · 0

    TITLE: SCLERAL FIXATION OF SINGLE-PIECE FOLDABLE IOL USING DOUBLE-FLANGED TECHNIQUE. THE PURPOSE OF THE STUDY IS TO DESCRIBE THE EFFICIENCY AND VISUAL RESULTS OF A NEW METHOD OF TRANSCONJUNCTIVAL INTRASCLERAL FIXATION OF SINGLE-PIECE FOLDABLE IOL USING DOUBLE-FLANGED 6/0 PROLENE SUTURE (ETHICON). BETWEEN (B)(6) 2019 AND (B)(6) 2022, 17 APHAKIC EYES OF 17 PATIENTS WITHOUT ADEQUATE CAPSULAR SUPPORT UNDERWENT TRANSCONJUNCTIVAL INTRASCLERAL FIXATION OF FOLDABLE SINGLE-PIECE IOLS AND WERE INCLUDED IN THIS STUDY. THERE WERE 7 MALES AND 10 FEMALES WITH A MEAN AGE OF 52.7± 17.1 YEARS. DURING THE PROCEDURE, THELLENS WAS PREPARED BY PASSING THE 6/0 PROLENE SUTURE (ETHICON) IN A TRACK IN THE HAPTIC OF SINGLE-PIECE FOLDABLE IOL CREATED BY 31 G NEEDLE. THE 6/0 PROLENE SUTURE (ETHICON) WAS RETRIEVED THROUGH A 30 G NEEDLE TRANSCONJUNCTIVALLY TO OUTSIDE THE GLOBE; THEN, IOL WAS IMPLANTED, AND A TERMINAL BULB WAS CREATED AT THE OUTER END OF THE PROLENE SUTURE (ETHICON). PATIENTS WERE TREATED WITH TOPICAL BROAD SPECTRUM ANTIBIOTIC DROPS, TOPICAL STEROID DROPS AND TOPICAL NSAIDS DROP. THE TOPICAL ANTIBIOTIC AND NSAIDS WERE STOPPED AFTER 2 WEEKS AND THE TOPICAL STEROID WAS TAPERED OVER 4 WEEKS. THE CASES WERE FOLLOWED UP FOR AT LEAST THREE MONTHS FOR THE UNCORRECTED VISUAL ACUITY, BEST-CORRECTED VISUAL ACUITY, IOP, IOL CENTRATION, SPECULAR MICROSCOPY, LENS STABILITY AND PRESENCE OF COMPLICATIONS. REPORTED COMPLICATIONS INCLUDED SLIPPAGE OF THE PROLENE FILAMENT FROM THE HAPTIC AFTER IMPLANTATION (N=2), ROLLING OF THE PROLENE OVER EACH OTHER INSIDE THE INJECTOR TO CREATE A CONFLICT BETWEEN THE FILAMENTS THAT PREVENTS PLACEMENT OF THE IOL AFTER IMPLANTATION (N=1), EXPOSURE OF THE PROLENE BULB THROUGH THE CONJUNCTIVA (N=1), AND MILD CORNEAL EDEMA (N=2). IN CONCLUSION, TRANSCONJUNCTIVAL INTRASCLERAL FIXATION OF FOLDABLE SINGLE-PIECE IOLS IS A SAFE EFFICIENT METHOD FOR CORRECTING APHAKIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431711 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention