BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24222452 · Received January 30, 2026

    Report

    Report Number
    2210968-2026-01119
    Event Type
    Injury
    Date Received
    January 30, 2026
    Date of Event
    May 19, 2025
    Report Date
    January 30, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 CLIN MED. 2025 MAY 19;14(10):3545. HTTPS://DOI.ORG/10.3390/JCM14103545. PMID: 40429540; PMCID: PMC12112645.

    Description of Event or Problem · 0

    TITLE: EFFICACY AND SAFETY OF OPEN-CONJUNCTIVA AB EXTERNO 63 UM VS. 45 UM XEN GEL STENT IN GLAUCOMA SURGERY: ONE-YEAR FOLLOW-UP. THIS RETROSPECTIVE, NON-RANDOMIZED, SINGLE-CENTER COHORT STUDY AIMS TO COMPARE THE EFFICACY AND SAFETY OF THE XEN 63 UM AND 45 UM DEVICES WITH THE AB EXTERNO OPEN CONJUNCTIVA WITH A 30G NEEDLE APPROACH. A TOTAL OF 28 EYES FROM 27 PATIENTS WHO HAD UNDERGONE AEO XEN 63 UM IMPLANTATION AND 28 EYES FROM 28 PATIENTS WITH AN AEO XEN 45 UM IMPLANT, WHILE USING 7.0 VICRYL. REPORTED COMPLICATIONS ARE: 7.0 VICRYL. N=1 WOUND LEAK. TREATMENT: CONTACT LENS. N=1 DYSESTHETIC BLEB WITH SECONDARY DELLEN. TREATMENT: UNDERWENT SURGICAL REVISION. N=1 ANTERIOR SEGMENT SYNDROME (TASS), WITH IOP SPIKE, URRETZ¿ZAVALIA SYNDROME, AND CORNEAL DECOMPENSATION, POOR IOP CONTROL. TREATMENT: DESCEMET STRIPPING AUTOMATED ENDOTHELIAL KERATOPLASTY (DSAEK) AND TBT N=19 POSTOPERATIVE HYPOTONY. TREATMENT: NOT REPORTED. N=5 SEROUS CHOROIDAL DETACHMENT. TREATMENT: CONSERVATIVE MANAGEMENT, REST, AND ADJUSTED TOPICAL TREATMENT (TOPICAL MYDRIATICS EVERY 8 H AND TOPICAL PHOSPHATE DEXAMETHASONE EVERY 2 H, WITH PROGRESSIVE TAPERING). N=1 LOCALIZED HEMORRHAGIC CHOROIDAL ASSOCIATED WITH HYPOTONIC KERATOPATHY AND HYPOTONIC MACULOPATHY. TREATMENT: CONSERVATIVE MANAGEMENT, REST, AND ADJUSTED TOPICAL TREATMENT (TOPICAL MYDRIATICS EVERY 8 H AND TOPICAL PHOSPHATE DEXAMETHASONE EVERY 2 H, WITH PROGRESSIVE TAPERING). N=1 SUSTAINED HYPOTONY AND SEROUS CHOROIDAL DETACHMENT. TREATMENT: ANTERIOR CHAMBER REFORMATION WITH VISCOELASTIC WAS PERFORMED IN THE ANTERIOR CHAMBER. N=1 POSTOPERATIVE CYSTOID MACULAR EDEMA. TREATMENT: ONE DOSE OF SUB-TENON¿S TRIAMCINOLONE. IN CONCLUSION, THIS STUDY HELPS CONTRIBUTE TO THE LIMITED EVIDENCE ON THE COMPARISON BETWEEN BOTH DEVICES USING THE AEO APPROACH. BASED ON OUR FINDINGS AND THE PRELIMINARY DATA, WE SUGGEST THAT IN PATIENTS WITH HIGHER BASELINE IOP OR SEVERE GLAUCOMA, THE 63 UM DEVICE MAY BE PREFERRED OVER THE 45 UM DEVICE. IN CASES WITH HYPOTONY PREDISPOSING OPHTHALMOLOGICAL OR SYSTEMIC CONDITIONS, WE BELIEVE THE 45 UM DEVICE SHOULD BE PRIORITIZED TO ENSURE A SAFER POSTOPERATIVE COURSE. PROSPECTIVE STUDIES AND RANDOMIZED CLINICAL TRIALS WITH EXTENDED FOLLOW-UP AND A LARGER SAMPLE SIZE ARE NECESSARY TO CONFIRM THESE FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286607 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention