Coated VICRYL J555GRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10705031041219), received between Feb 23, 2021 and Sep 25, 2024 — classified as 18 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (19 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306879 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306875 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306874 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306872 ↗
• MalfunctionSep 25, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE PULLED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306871 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN UNCOMFORTABLE REACTION AFTER USAGE OF THE SUTURE THAT OCCURRED AROUND THE WOUND CLOSURE AREA. THE PATIENT WAS REFERRED TO A CORNEA SPECIALIST AND TOOK STEROIDS TO EASE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 18935414 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, THE PATIENT EXPERIENCED AN UNCOMFORTABLE REACTION AFTER USAGE OF THE SUTURE THAT OCCURRED AROUND THE WOUND CLOSURE AREA. THE PATIENT WAS REFERRED TO A CORNEA SPECIALIST AND TOOK STEROIDS TO EASE INFLAMMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation

  MAUDE report 18935412 ↗
• MalfunctionMar 5, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS FOUND TO BE FRAYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841652 ↗
• MalfunctionMar 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING SURGERY, SUTURE WAS FOUND TO BE FRAYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819055 ↗
• MalfunctionMar 1, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. DURING SURGERY, SUTURE WAS FOUND TO BE FRAYING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18819001 ↗
• 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 18714809 ↗
• 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 18714801 ↗
• 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 18714741 ↗
• 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 18714700 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18548007 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18548006 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18548005 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18548001 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547999 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547998 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547991 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547989 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547973 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE.

  Patient problems: Granuloma

  MAUDE report 18547971 ↗
• InjuryJan 19, 2024Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem; Material Frayed; Defective Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT STRABISMUS SURGERY ON AN UNKNOWN DATE AND SUTURE WAS USED. THE CLINICIAN OPINES THAT IN THE LAST 3 YEARS HE HAS EXPERIENCED A PROGRESSIVE DETERIORATION IN THE QUALITY OF SUTURE THREAD. THE PATIENT EXPERIENCED FORMATION OF GRANULOMAS RELATED TO CONJUNCTIVAL FLAPS. THE SURGEON ALSO STATED THAT WHEN THE THREAD GETS WET IT LOSES ITS HOMOGENEITY OF WEAVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT A REVISION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Granuloma

  MAUDE report 18547967 ↗

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