BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24364412 · Received February 17, 2026

    Report

    Report Number
    2210968-2026-01671
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    December 27, 2025
    Report Date
    February 17, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: J VITREORETIN DIS. 2025 DEC 27:24741264251400705. HTTPS://DOI.ORG/10.1177/24741264251400705. EPUB AHEAD OF PRINT. PMID: 41466839; PMCID: PMC12743643.

    Description of Event or Problem · 0

    TITLE: SCLERAL IMBRICATION SUTURES PROVIDE TEMPORARY OR SUSTAINED VITREOUS BASE INDENTATION AS AN ADJUVANT TO PARS PLANA VITRECTOMY FOR RETINAL DETACHMENT REPAIR. THE AIM OF THIS STUDY IS TO ANALYZE VITREOUS BASE INDENTATION ACHIEVED WITH ABSORBABLE VS PERMANENT SCLERAL IMBRICATION SUTURES DURING RETINAL DETACHMENT REPAIR. BETWEEN MAY AND DECEMBER 2023, THIS RETROSPECTIVE, CONSECUTIVE CASE SERIES INCLUDED PATIENTS WHO UNDERWENT SCLERAL IMBRICATION SUTURES WITH PARS PLANA VITRECTOMY (PPV) FOR PRIMARY RHEGMATOGENOUS RETINAL DETACHMENT (RRD) REPAIR. CONSECUTIVE PATIENTS AGED 18 YEARS OR OLDER WHO UNDERWENT PPV WITH SCLERAL IMBRICATION SUTURE PLACEMENT WERE INCLUDED. ALL EYES HAD RRD WITH 3 OR FEWER BREAKS. ELEVEN PATIENTS (69%) WERE MALE, AND 10 EYES (63%) WERE PHAKIC. SINGLE-SURGERY ANATOMIC SUCCESS RATE AND VISUAL ACUITY (VA) WERE ASSESSED AT 6 TO 9 MONTHS POSTOPERATIVELY. SCLERAL INDENTATION WAS MEASURED BY B-SCAN ULTRASONOGRAPHY MORE THAN 6 WEEKS AFTER SURGERY. AFTER PERFORMING A 360-DEGREE PERITOMY AND ISOLATING THE 4 RECTUS MUSCLES WITH 2-0 SILK SUTURES, PARTIAL THICKNESS 6 BY 6 MM MATTRESS SUTURES WERE PLACED DIRECTLY POSTERIOR TO THE RECTUS MUSCLE INSERTION PLANE IN EACH QUADRANT TO SHORTEN THE SCLERA AND INDENT THE VITREOUS BASE WITHOUT THE USE OF A SCLERAL BUCKLE ELEMENT. THE 6 BY 6 MM MATTRESS SUTURE PLACEMENT WAS SELECTED TO PROVIDE SUFFICIENT SUPPORT FOR THE VITREOUS BASE TO SIMULATE A BUCKLE EFFECT WHEN PLACED IN EACH QUADRANT. EITHER 5-0 POLYESTER OR 5-0 POLYGLACTIN 910 SUTURES WERE USED. IN MOST CASES, A POLYESTER SUTURE WAS PLACED IN THE QUADRANT OF THE PRIMARY BREAK, AND POLYGLACTIN 910 SUTURES WERE USED IN THE REMAINING 3 QUADRANTS. PPV WAS PERFORMED USING 23-GAUGE VITRECTOMY SYSTEMS (ALCON CONSTELLATION) AND A WIDEFIELD OPERATING MICROSCOPE SYSTEM (CARL ZEISS MEDITEC). THE MEDIAN FOLLOW-UP DURATION WAS 205 DAYS (IQR, 170-273 DAYS). THE MEDIAN FOLLOW-UP FOR THE MOST RECENT POSTOPERATIVE B-SCAN ULTRASONOGRAPHY WAS 75 DAYS (IQR, 57-133 DAYS). REPORTED COMPLICATIONS: 5-0 POLYGLACTIN 910 SUTURES VICRYL SUTURE (ETHICON): 2-0 SILK SUTURES (ETHICON): (N=6)CATARACT PROGRESSION IN 60% (6 OF 10 PHAKIC EYES) TREATMENT: NOT REPORTED (N=3) RECURRENT RETINAL DETACHMENT IN 19% (3 OF 16 EYES) TREATMENT: NOT REPORTED (N=13% (2 OF 16 EYES)) ATTRIBUTABLE TO PROLIFERATIVE VITREORETINOPATHY (PVR) TREATMENT: NOT REPORTED (N=1) OCCURRING AS A LATE-ONSET (7-MONTH) COMPLICATION TREATMENT: NOT REPORTED (N=1) RESULTING FROM A NEW OR MISSED RETINAL TEAR TREATMENT: NOT REPORTED (N=2) INTRAOCULAR PRESSURE ELEVATION IN 13% (2 OF 16 EYES) TREATMENT: REQUIRING MEDICAL TREATMENT (N=1) EPIRETINAL MEMBRANE FORMATION IN 6% (1 OF 16 EYES) TREATMENT: NOT REPORTED (N=1) CYSTOID MACULAR EDEMA IN 6% (1 OF 16 EYES) TREATMENT: NOT REPORTED (N=1) DIPLOPIA IN 6% (1 OF 16 EYES) TREATMENT: WHICH WAS RESOLVED BY 6 MONTHS. IN CONCLUSION, TO OUR KNOWLEDGE, THIS REPRESENTS THE LARGEST CASE SERIES TO DATE EVALUATING SCLERAL IMBRICATION SUTURES AS AN ADJUVANT TO PPV FOR PRIMARY RRD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242226 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention