GORE-TEX Suture 8K10Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-8 61cm DoubleArm TTc-7-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132629862), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2022Break; Break
THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: MUTH, D. R., WOLF, A., KREUTZER, T., SHAJARI, M., VOUNOTRYPIDIS, E., PRIGLINGER, S. AND MAYER, W. J. (2021). 'SAFETY AND EFFICACY OF CURRENT SCLERA FIXATION METHODS FOR INTRAOCULAR LENSES AND LITERATURE OVERVIEW', KLIN MONBL AUGENHEILKD, 238(8), PP. 868-874. THIS ARTICLE EVALUATES THE 3 CURRENTLY MOST COMMON TECHNIQUES FOR INTRAOCULAR LENS (IOL) SCLERAL FIXATION. THE 4-POINT GORE-TEX® SUTURE TECHNIQUE BEING ONE OF THEM. ENROLLED IN THE STUDY WERE 51 PATIENTS WITH A TOTAL OF 55 EYES WITH SCLERAL IOL FIXATION BETWEEN JANUARY 2014 AND SEPTEMBER 2019. THE INTRASCLERAL FIXATION BY GORE-TEX® SUTURE (CV-8) WAS PERFORMED IN 14 EYES (TOTAL OF 12 PATIENTS). TWO OF THESE EYES REQUIRED REFIXATION, ONE OF THEM DUE TO THE PATIENT HAVING A RE-DISLOCATION OF HIS IOL DUE TO RUPTURE OF THE SUTURE.
Patient problems: Insufficient Information
MAUDE report 15127980 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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