A.C.S® (Alcon Closure System) 8065692101Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type AU-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 00380656921011), received between Oct 24, 2023 and May 26, 2025 — classified as 8 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, Blunt3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING SURGERY AN OPHTHALMIC SUTURE WAS FOUND THINNER THAN NORMAL AND WAS BREAKING. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE WITH NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084245 ↗MalfunctionApr 21, 2025Break; Break
A NURSE REPORTED THAT AN OPHTHALMIC SUTURE THAT BROKE EASILY DURING CATARACT / VITRECTOMY COMBINATION SURGERY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872879 ↗MalfunctionOct 24, 2024Break; Break
A CUSTOMER REPORTED THAT DURING DESCEMET MEMBRANE ENDOTHELIAL KERATOPLASTY AN OPHTHALMIC SUTURES WAS BREAKING. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20520391 ↗MalfunctionSep 3, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY, BLADE OF SUTURE WAS DULL. SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT AND WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20123573 ↗MalfunctionJun 20, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SUTURE NEEDLE NOT SHARP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574038 ↗MalfunctionJun 17, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SUTURE NEEDLE WAS NOT SHARP. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547145 ↗MalfunctionOct 27, 2023Break; Break
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC SUTURE CUT . THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18020065 ↗MalfunctionOct 24, 2023Break; Break
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SUTURE TORE. SURGERY WAS COMPLETED BY USING AN ALTERNATE SUTURE WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994065 ↗
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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