Coated VICRYL J547GRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10705031041110), received between Sep 25, 2019 and Mar 21, 2025 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K022269); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2025Break; Material Frayed; Break; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, VICRYL 8-0 IS PASSED AND THE SUTURE FRAYS AND BREAKS EASILY, SO ANOTHER SUTURE MUST BE PASSED. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662559 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, STITCHES ARE PASSED AND THE NEEDLE IS FRAYED AND WHEN THE KNOT IS TIGHTENED THE SUTURE IS TORN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265756 ↗
• MalfunctionJan 29, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, STITCHES ARE PASSED AND THE NEEDLE IS FRAYED AND WHEN THE KNOT IS TIGHTENED THE SUTURE IS TORN. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265748 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT EXPERIENCED DISCOMFORT INCLUDING YELLOWING OF THE EYEBALLS. THERE WAS NO SUTURE DEFICIENCY NOTED BEFORE OR DURING USE. POST OP EXAMINATION SHOWED INCREASED INFLAMMATORY RESPONSE. VIGAMOX OPHTHALMIC DROPS, LOTEMAX OPHTHALMIC GEL AND/OR PREDNISONE FORTE 1% OPHTHALMIC DROPS WERE USED TO TREAT THE INFLAMMATORY RESPONSE. THERE WAS NO SURGICAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation

  MAUDE report 10946444 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT EXPERIENCED DISCOMFORT INCLUDING YELLOWING OF THE EYEBALLS. THERE WAS NO SUTURE DEFICIENCY NOTED BEFORE OR DURING USE. POST OP EXAMINATION SHOWED INCREASED INFLAMMATORY RESPONSE. VIGAMOX OPHTHALMIC DROPS, LOTEMAX OPHTHALMIC GEL AND/OR PREDNISONE FORTE 1% OPHTHALMIC DROPS WERE USED TO TREAT THE INFLAMMATORY RESPONSE. THERE WAS NO SURGICAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation

  MAUDE report 10946393 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PTERYGIUM SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT EXPERIENCED DISCOMFORT INCLUDING YELLOWING OF THE EYEBALLS. THERE WAS NO SUTURE DEFICIENCY NOTED BEFORE OR DURING USE. POST OP EXAMINATION SHOWED INCREASED INFLAMMATORY RESPONSE. VIGAMOX OPHTHALMIC DROPS, LOTEMAX OPHT EYEHALMIC GEL AND/OR PREDNISONE FORTE 1% OPHTHALMIC DROPS WERE USED TO TREAT THE INFLAMMATORY RESPONSE. THERE WAS NO SURGICAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation

  MAUDE report 10946308 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT EXPERIENCED DISCOMFORT INCLUDING YELLOWING OF THE EYEBALLS. THERE WAS NO SUTURE DEFICIENCY NOTED BEFORE OR DURING USE. POST OP EXAMINATION SHOWED INCREASED INFLAMMATORY RESPONSE. VIGAMOX OPHTHALMIC DROPS, LOTEMAX OPHTHALMIC GEL AND/OR PREDNISONE FORTE 1% OPHTHALMIC DROPS WERE USED TO TREAT THE INFLAMMATORY RESPONSE. THERE WAS NO SURGICAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation

  MAUDE report 10946303 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A STRABISMUS SURGERY ON (B)(6) 2020 AND THE SUTURE WAS USED. AFTER THE SURGERY, THE PATIENT EXPERIENCED DISCOMFORT INCLUDING YELLOWING OF THE EYEBALLS. THERE WAS NO SUTURE DEFICIENCY NOTED BEFORE OR DURING USE. POST OP EXAMINATION SHOWED INCREASED INFLAMMATORY RESPONSE. VIGAMOX OPHTHALMIC DROPS, LOTEMAX OPHTHALMIC GEL AND/OR PREDNISONE FORTE 1% OPHTHALMIC DROPS WERE USED TO TREAT THE INFLAMMATORY RESPONSE. THERE WAS NO SURGICAL INTERVENTION PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Inflammation

  MAUDE report 10945603 ↗
• MalfunctionSep 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2020; AND A SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE DETACHED FROM THE NEEDLE. IT WAS NOT A CONTROL RELEASE NEEDLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531002 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119107 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119106 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119100 ↗

Recalls under the same FDA submission

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

• 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