A.C.S® (Alcon Closure System) 8065208001Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type CU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,Single 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
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652080019), received between Dec 21, 2023 and Aug 28, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break5
- Dull, Blunt2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50499727 ↗InjuryAug 28, 2026Break
A healthcare professional reported that during glaucoma shunt implant surgery an ophthalmic suture filament broke off between a needle holder and tying forceps in patient¿s left eye. The broken suture was replaced, and tissue had to be re-sutured again with no further impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497103 ↗MalfunctionDec 17, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT MULTIPLE OPHTHALMIC SUTURES FROM THE SAME BATCH BROKE WHILE ATTEMPTING TO SUTURE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23830496 ↗MalfunctionAug 18, 2025Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT THE OPHTHALMIC SUTURE TIPS WERE FOUND BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT OCCURRED DURING SURGERY AND THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22828366 ↗MalfunctionAug 11, 2025Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT TWO OF THE OPHTHALMIC SUTURE NEEDLES FROM SAME LOT WERE BLUNT. AN ALTERNATIVE NEEDLE WAS USED TO COMPLETE THE SURGERY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22768958 ↗MalfunctionDec 22, 2023Break; Break
A PHYSICIAN REPORTED THAT OPHTHALMIC SUTURE MATERIAL WAS BREAKING ON USE. THE SUTURE PACKAGE CANNOT BE OPENED AS IT HAS BEEN SEALED. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380642 ↗InjuryDec 21, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT THE OPHTHALMIC SUTURES MISSING FROM PATIENT¿S EYE AFTER SURGERY AND PATIENT WAS RETURNED TO THE OPERATION THEATRE AFTER THREE DAYS OF SURGARY. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18380562 ↗
Other Suture, Nonabsorbable, Synthetic, Polyamide devices
- ETHILON 697GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHILON 698GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls2 reports
- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S697GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls1 report
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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