Coated VICRYL J391HRecalls & reported problems
Ethicon, LLC · Violet Braided (Polyglactin 910), Synthetic Absorbable Suture · Class 2 · Implant
All models of Coated VICRYL (350)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031039513), received between Jun 15, 2023 and Jun 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
Device problems
- Break4
Patient problems
- Insufficient Information4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN EYE PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST-OP, IT WAS REPORTED A FAILED CHERRY EYE SURGERIES RECENTLY AND THE SPECIALIST SAID IT WAS POSSIBLY DUE TO THE SUTURES SINCE THIS IS USUALLY A HIGHLY SUCCESSFUL SURGERY.¿ON JUNE 5, 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17134314 ↗MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED A FAILED CHERRY EYE SURGERIES RECENTLY AND THE SPECIALIST SAID IT WAS POSSIBLY DUE TO THE SUTURES SINCE THIS IS USUALLY A HIGHLY SUCCESSFUL SURGERY.¿ ON JUNE 5, 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17134164 ↗MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED A FAILED CHERRY EYE SURGERIES RECENTLY AND THE SPECIALIST SAID IT WAS POSSIBLY DUE TO THE SUTURES SINCE THIS IS USUALLY A HIGHLY SUCCESSFUL SURGERY. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17134158 ↗MalfunctionJun 15, 2023Break; Break
IT WAS REPORTED AN ANIMAL UNDERWENT AN EYE PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. POST-OP, IT WAS REPORTED A FAILED CHERRY EYE SURGERIES RECENTLY AND THE SPECIALIST SAID IT WAS POSSIBLY DUE TO THE SUTURES SINCE THIS IS USUALLY A HIGHLY SUCCESSFUL SURGERY.¿ ON (B)(6)2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17134156 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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