Coated VICRYL J446GRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031039971), received between Mar 25, 2020 and Jun 21, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2022Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A SUTURE WAS USED. DURING SURGERY, THE SUTURE WAS DETACHED FROM THE NEEDLE DURING USE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14757839 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT UNILATERAL STRABISMUS SURGERY ON (B)(6) 2020 AND SUTURE WAS USED ON THE MUSCLE. THE PROCEDURE WAS PERFORMED BY SIMULTANEOUS ROTATION METHOD AND REVERSE ROTATION METHOD. AFTER THE SURGERY, RINDERON WAS ADMINISTERED. AFTER A WEEK, DURING FOLLOW-UP INSPECTION, THE PATIENT COMPLAINED THAT THE VIEW WAS SLIGHTLY VAGUE. POST-OP IT WAS REPORTED THAT THE PATIENT MAY HAVE EXPERIENCED PAPILLITIS. EYE INFLAMMATION WAS SUSPECTED, SO THE PATIENT VISITED UNIVERSITY HOSPITAL, AND THE SYMPTOM WAS DIAGNOSED AS UVEITIS. RINDERON WAS ADMINISTERED AGAIN, AND THE PATIENT HAS BEEN UNDER FOLLOW-UP. THE SURGEON OPINED THAT THE SUTURE MIGHT HAVE BEEN RELATED TO THE SYMPTOM. IT WAS REPORTED THE SURGEON OPINED THAT INFLAMMATORY REACTION CAN HAPPEN DURING THE HYDROLYSIS PROCESS OF SUTURES. SURGEON OPINED THEY DID NOT THINK THAT THE SUTURE WAS THE DIRECT CAUSE. A CONTRIBUTING FACTOR WAS REPORTED TO BE THAT THERE IS A POSSIBILITY THAT INFECTION OCCURRED BECAUSE THE PATIENT TOUCHED THE EYE WITH A HAND. THE PATIENT VISITS THE HOSPITAL REGULARLY. TREATMENT PLAN WILL BE DETERMINED ON FOLLOW-UP. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Inflammation

  MAUDE report 9879051 ↗

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