A.C.S® (Alcon Closure System) 8065192101Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type CU-5,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 12,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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380651921016), received between May 30, 2024 and Nov 3, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Break7
- Dull, Blunt1
- Material Discolored1
- Material Split, Cut or Torn1
- Unexpected Color1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING PENETRATING KERATOPLASTY SURGERY, AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE DULL AND TAKES TOO MUCH EFFORT TO GET IT THROUGH THE CORNEAL TISSUE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE SUTURE. THERE WAS NO PATIENT HARM. THIS COMPLAINT REPRESENTS FIRST OF TWO COMPLAINTS REPORTED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449803 ↗MalfunctionJul 25, 2025Break; Break
A CUSTOMER REPORTED THAT TWO OF THE OPHTHALMIC SUTURES FROM DIFFERENT LOTS WERE BRITTLE AND BROKE EASILY. 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 22610248 ↗MalfunctionJul 25, 2025Break; Break
A CUSTOMER REPORTED THAT TWO OF THE OPHTHALMIC SUTURES FROM DIFFERENT LOTS WERE BRITTLE AND BROKE EASILY. 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 22610220 ↗MalfunctionMay 22, 2025Break; Break
A NURSE REPORTED THAT DURING SURGERY, THE OPHTHALMIC SUTURES WERE BREAK. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22069212 ↗MalfunctionMay 22, 2025Break; Break
A NURSE REPORTED THAT DURING SURGERY, THE OPHTHALMIC SUTURES WERE BREAK. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22069114 ↗MalfunctionMay 22, 2025Break; Break
A NURSE REPORTED THAT DURING SURGERY, THE OPHTHALMIC SUTURES WERE BREAK. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22069109 ↗MalfunctionOct 3, 2024Break; Material Discolored; Break; Material Discolored
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY, AN OPHTHALMIC SUTURE BROKE WHILE BEING TIED. IT WAS FURTHER REPORTED THAT THE SUTURES WERE DISCOLORED THE SURGERY WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SUTURE FROM THE SAME PACKAGE. THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20364138 ↗MalfunctionMay 30, 2024Break; Material Split, Cut or Torn; Unexpected Color; Break; Material Split, Cut or Torn; Unexpected Color
A NURSE REPORTED THAT THE OPHTHALMIC SUTURES FROM TWO DIFFERENT LOTS WERE UNUSUAL IN COLOR, THINNER THAN NORMAL, AND BROKE EASILY PRIOR TO SURGERY. PROCEDURE DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEE REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19423023 ↗
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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