A.C.S® (Alcon Closure System) 8065698001Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type AU-1,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
Quick summary
This Alcon A.C.S. suture is a 10-0 black nylon ophthalmic suture used for closing eye wounds, most often in cataract surgery. Most of the 74 reports describe the thread snapping while the surgeon tied it, which sometimes split the incision and delayed the operation; 10 reports involved an injury and no deaths were reported. Some also mention thread that looks dull or discolored, and a few arrive already broken in the package. No recalls name this device, and report numbers are similar to the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00380656980018), received between Apr 25, 2022 and Sep 25, 2026 — classified as 9 injuries, 64 malfunctions.
The most frequently reported specific device problem is “Break” (56 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
- Break56
- Material Split, Cut or Torn10
- Adverse Event Without Identified Device or Use Problem7
- Dull, Blunt5
- Packaging Problem3
- Material Discolored2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information26
- Hyperemia4
- Red Eye(s)4
- Conjunctivitis3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema1
- Discomfort1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Packaging Problem
A physician reported that, during surgery white ophthalmic suture was found inside the pack instead of black suture when the package was opened. The surgery was completed on the same day without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898731 ↗MalfunctionSep 25, 2026Packaging Problem
A physician reported that, during surgery white ophthalmic suture was found inside the pack instead of black suture when the package was opened. The surgery was completed on the same day without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898730 ↗MalfunctionSep 25, 2026Packaging Problem
A physician reported that, during surgery white ophthalmic suture was found inside the pack instead of black suture when the package was opened. The surgery was completed on the same day without any patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50898727 ↗MalfunctionJul 15, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25826358 ↗MalfunctionApr 24, 2026Break
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY, NINE OPHTHALMIC SUTURES WERE FOUND BROKEN. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984390 ↗MalfunctionMar 20, 2026Break
A GOVERNMENT AGENCY REPORTED THAT DURING CONJUNCTIVAL TRANSPLANTATION AND WOUND SUTURING, AN OPHTHALMIC SUTURE BROKE. THE SUTURE WAS REPLACED, AND THE SURGERY WAS COMPLETED ON THE SAME DAY. PATIENT IMPACT HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24649479 ↗MalfunctionMar 6, 2026Break; Material Split, Cut or Torn
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC SUTURE WAS VERY THIN AND BROKEN DURING KNOT TYING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS IS THE SECOND OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24528225 ↗MalfunctionMar 6, 2026Break; Material Split, Cut or Torn
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC SUTURE WAS VERY THIN AND BROKEN DURING KNOT TYING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS IS THE SECOND OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24528221 ↗MalfunctionMar 6, 2026Break; Material Split, Cut or Torn
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC SUTURE WAS VERY THIN AND BROKEN DURING KNOT TYING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS REPORT PERTAINS TO ONE OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24528213 ↗MalfunctionMar 6, 2026Break; Material Split, Cut or Torn
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC SUTURE WAS VERY THIN AND BROKEN DURING KNOT TYING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS REPORT PERTAINS TO ONE OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24528209 ↗MalfunctionJan 28, 2026Break
THE PHYSICIAN REPORTED THAT OPHTHALMIC SUTURES WERE BROKEN BEFORE THE SURGERY. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199927 ↗MalfunctionJan 28, 2026Break
THE PHYSICIAN REPORTED THAT OPHTHALMIC SUTURES WERE BROKEN BEFORE THE SURGERY. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199916 ↗MalfunctionJan 12, 2026Break
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SUTURE BROKE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034501 ↗MalfunctionJan 1, 2026Break
A GOVERNMENT AGENCY REPORTED THAT DURING SURGERY OPHTHALMIC SUTURE REPEATEDLY BROKE WHILE TYING KNOTS. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ALTERNATIVE SUTURE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23939460 ↗MalfunctionDec 31, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING SURGERY, THREE CONSECUTIVE OPHTHALMIC SUTURE THREADS FROM THE SAME BATCH BROKE WHILE SUTURING. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932152 ↗MalfunctionDec 19, 2025Break; Dull, Blunt; Break; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR IMPLANTATION, OPHTHALMIC SUTURE TENDS TO BREAK EASILY AND THE NEEDLE WAS VERY BLUNT. PROCEDURE WAS COMPLETED ON THE SAME DAY. PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 23849822 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT A PATIENT EXPERIENCED CONJUNCTIVAL REDNESS AND SWELLING APPEARED AFTER SURGERY. THE DETAILS OF THE PROCEDURE AND EVENT WAS NOT PROVIDED. NO PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.
Patient problems: Red Eye(s)
MAUDE report 23790572 ↗InjuryDec 12, 2025Break; Break
A GOVERNMENT AGENCY REPORTED THAT DURING SLIT-LAMP EXAMINATION REVEALED TWO SUTURES AT THE CORNEOSCLERAL LIMBUS IN PLACE, WITH THE SUTURE IN THE SUPERIOR NASAL AREA BROKEN. THE CONJUNCTIVAL FLAP SHOWED SLIGHT MISALIGNMENT; THE CORNEAL WOUND WAS SMOOTH, WITH NO PURULENT DISCHARGE, AND THE REMAINING CORNEA WAS CLEAR. THE PATIENT FAILED TO STRICTLY FOLLOW POSTOPERATIVE INSTRUCTIONS AND FORCEFULLY RUBBED THE OPERATED EYE, RESULTING IN MECHANICAL SUTURE BREAKAGE. SUBSEQUENTLY, UNDER STRICT ASEPTIC CONDITIONS, THE PATIENT UNDERWENT CONJUNCTIVAL FLAP RE-SUTURING OF THE LEFT EYE IN THE TREATMENT ROOM. THE CURRENT PATIENT OUTCOME IS UNKNOWN.
Patient problems: Hyperemia; Intraocular Pressure Increased; Red Eye(s)
MAUDE report 23790101 ↗MalfunctionDec 9, 2025Break; Break
A PHYSICIAN REPORTED THAT BEFORE SURGERY OPHTHALMIC SUTURE WAS BROKEN WHEN IT WAS OPENED. THE SURGERY COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23755886 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A GOVERNMENT AGENCY REPORTED THAT OPHTHALMIC SUTURES WERE FOR THE VITRECTOMY SURGERY POST OPERATIVE THE PATIENT EXPERIENCED REDNESS AND SWELLING IN EYE. THE PATIENT WAS GIVEN ANTIBIOTIC EYE DROPS WERE IMMEDIATELY GIVEN AFTER THIRTY MINUTES, THE DISCOMFORT GRADUALLY DISAPPEARED. THE CURRENT OUTCOME OF THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: Corneal Edema; Red Eye(s)
MAUDE report 23741618 ↗MalfunctionNov 6, 2025Break; Break
A PHYSICIAN REPORTED THAT OPHTHALMIC SUTURES FROM TWO DIFFERENT BATCHES BROKE BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED. THIS REPORT IS PERTAINING TO ONE OF TWO DIFFERENT BATCH REPORTED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484199 ↗MalfunctionNov 6, 2025Break; Break
A PHYSICIAN REPORTED THAT OPHTHALMIC SUTURES FROM TWO DIFFERENT BATCHES BROKE BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER THE PRODUCT WAS REPLACED. THIS REPORT IS PERTAINING TO ONE OF TWO DIFFERENT BATCH REPORTED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484196 ↗MalfunctionOct 31, 2025Break; Break
A GOVERNMENT AGENCY REPORTED THAT DURING THE PROCESS OF SUTURING THE CONJUNCTIVA WITH NON-ABSORBABLE SURGICAL SUTURE DURING SURGERY, IT WAS REPEATEDLY FOUND THAT THE SUTURE WAS PRONE TO BREAKAGE. PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE SUTURE. PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23436894 ↗MalfunctionOct 30, 2025Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT OPHTHALMIC NEEDLE WAS FOUND TO BE BLUNT AND DIFFICULT TO PENETRATE TISSUE DURING USE. THE SURGERY WAS CONTINUED AFTER REPLACING THE NEEDLE WITH ANOTHER ONE ON THE SAME DAY. THE DETAILS OF THE PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 23424275 ↗MalfunctionOct 17, 2025Break; Break
A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC SUTURE BROKE EASILY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23322558 ↗
Other Suture, Nonabsorbable, Synthetic, Polyamide devices
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- 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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