Coated VICRYL J590GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031041530), received between Dec 27, 2022 and Feb 15, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K022269, K183183); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 18714761 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 18714758 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma; Inflammation

  MAUDE report 18714750 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON THE EYE AND SUTURE WAS USED. POST-OP, THE PATIENT PRESENTED WITH INFLAMMATION. THE SURGEON PRESCRIBED STEROIDS TO CONTROL THE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Inflammation

  MAUDE report 18714749 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SQUINT SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THERE WAS AN ISSUE WITH THE SPATULA NEEDLE. THE SURGEON COMMENTED THAT THE NEEDLE SHREDDED THE EYE MUSCLE/ TENONS DURING THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 16051122 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022269, K183183. One submission often covers many models, so check the product and lot details in each record.

• Z-1513-2025 · Mar 7, 2025 · Open, Classified
  PDSPLUSVIO30IN(75CM)USP6-0(M0.7)D/AC-1MP
• Z-0319-2025 · Sep 25, 2024 · Open, Classified
  Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
• Z-2146-2024 · May 10, 2024 · Open, Classified
  PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery.
• Z-2144-2024 · May 10, 2024 · Open, Classified
  VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and
• Z-0989-2020 · Jan 3, 2020 · Terminated
  Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
• Z-1087-06 · May 4, 2006 · Terminated
  Coated Vicryl (polyglactin 910) suture. Needle Type CTXB Suture size: 1. Vicryl suture is a synthetic absorbable sterile surgical suture comprised of a copolymer made from 90% gyc