A.C.S® (Alcon Closure System) 8065710001Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type AU-5,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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380657100019), received between Aug 18, 2025 and Nov 5, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Crack2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2025Break; Crack; Break; Crack
A CUSTOMER REPORTED THAT NEEDLE BROKE, OR BEND AND THE SUTURE DID NOT SEEM AS STRONG AS BEFORE OF AN OPHTHALMIC SUTURE. THE PROCEDURE DETAILS AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23473755 ↗MalfunctionNov 5, 2025Break; Crack; Break; Crack
A CUSTOMER REPORTED THAT NEEDLE BROKE, OR BEND AND THE SUTURE DID NOT SEEM AS STRONG AS BEFORE OF AN OPHTHALMIC CLOSURE SYSTEM. THE PROCEDURE DETAILS AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS REPORT PERTAINING TO ONE OF THE TWO REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23473715 ↗MalfunctionAug 18, 2025Break; Break
A CUSTOMER REPORTED THAT DURING CATARACT EXTRACTION WITH INTRAOCULAR LENS PLACEMENT SURGERY, WHEN PLACING THE SUTURES INTO PATIENT EYE TO SECURE THE SULCUS LENS THE FOUR SUTURES FROM SAME LOT KEPT BREAKING RESULTED IN ANTERIOR VITRECTOMY. THE PROCEDURE WAS COMPLETED BY USING AN ALTERNATE SUTURE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828146 ↗
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 S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- McKesson S661GXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
- Surgilon 88861919-41Covidien LP · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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