A.C.S® (Alcon Closure System) 8065215201Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type R-5,Green Braided Polyester(GBP), Suture Size 5-0, Suture Length 18,Double Armed · Class 2 · Implant
All models of A.C.S (Alcon Closure System) (18)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652152013), received between Jul 18, 2024 and Jun 5, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Unsealed Device Packaging1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2025Unsealed Device Packaging; Unsealed Device Packaging
A NURSE REPORTED THAT DURING CATARACT SURGERY IT WAS FOUND THAT AN OPHTHALMIC SUTURE WAS IN A CONTAMINATED STATE AS THE PACKAGE WAS NOT SEALED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22148546 ↗MalfunctionJul 18, 2024Break; Break
A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC SURGICAL SUTURE NEEDLE WAS BROKEN DURING LEFT EYELID ECTROPION CORRECTION, FLAP REPAIR, AND INNER AND OUTER CANTHOPLASTY SURGERY. THE PATIENT UNDERWENT COMPUTED TOMOGRAPHY (CT) 7 FOR ORBITAL PLAIN SCAN AND THREE-DIMENSIONAL (3D) RECONSTRUCTION. IT WAS FOUND THAT THE BROKEN SUTURE NEEDLED WAS STILL IN THE PATIENT'S EYE. THE OTHER PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19769590 ↗
Other Suture, Nonabsorbable, Synthetic, Polyester devices
- BIOKNOTLESS PANACRYL ETHIBOND 212723Depuy Mitek, LLC · Suture, nonabsorbable, synthetic, polyester1 recall33 reports
- LUPINE ORTHOCORD 210711Medos International Sàrl · Suture, nonabsorbable, synthetic, polyester52 reports
- ALLthread Titanium 902591Biomet Orthopedics, LLC · Suture, nonabsorbable, synthetic, polyester2 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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