A.C.S® (Alcon Closure System) 8065710401Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type AU-1,Black Monofilament Nylon(BMN), Suture Size 10-0, Suture Length 6,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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380657104017), received between Jun 25, 2024 and Oct 25, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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
- Break4
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC SUTURE WAS BROKEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20532022 ↗MalfunctionJul 22, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, SEVERAL OPHTHALMIC SUTURES BROKE. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19790780 ↗MalfunctionJul 10, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SURGICAL SUTURE WAS BROKEN WHEN USED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER USING ANOTHER SUTURE. IT WAS ALSO REPORTED THAT ANOTHER UNIT WAS ALSO BROKEN, BUT ALLOWED TO COMPLETE THE SURGERY. THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19711292 ↗MalfunctionJun 25, 2024Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SURGICAL SUTURE WAS BROKEN DURING TRABECULECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER NEW SUTURE. IT WAS ALSO REPORTED THAT THE ISSUE HAD HAPPENED FOUR TO FIVE TIMES IN THE SAME SURGERY AND TIME CONSUMED TO OPEN THE NEW SUTURES. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605534 ↗
Other Suture, Nonabsorbable, Synthetic, Polyamide devices
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- 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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