A.C.S® (Alcon Closure System) 8065193001Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type C-3,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. nylon suture with a double-armed needle is used to close tissue, most often in eye surgery. The 57 reports mostly describe needles arriving dull or blunt, plus breakage and material problems like discoloration and cracking. No deaths and 4 injuries were reported, and no recalls name this device. Reports jumped from 1 in the prior 12 months to 50 in the latest 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
- 46
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380651930018), received between Jul 13, 2022 and Sep 30, 2026 — classified as 4 injuries, 42 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (35 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
- Dull, Blunt35
- Break10
- Material Discolored5
- Crack1
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Eye Pain3
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
A customer reported that during cataract surgery multiple sutures were observed to be blunt. The surgery was completed on the same day by using same sutures. The patient experienced pain while using the same sutures. The current condition of the patient was unknown. This complaint is pertaining the three of four patients received from the initial reporter.
Patient problems: Eye Pain
MAUDE report 50945687 ↗MalfunctionSep 29, 2026Dull, Blunt
A customer reported that few sutures were observed to be blunt during the cataract surgery with intraocular lens implantation. The surgery was completed on the same day by using same sutures. The patient experienced eye pain while using the same sutures. The current condition of the patient was unknown.This complaint is pertaining the two of four patients received from the initial reporter.
Patient problems: Eye Pain
MAUDE report 50934047 ↗MalfunctionSep 28, 2026Dull, Blunt
A physician reported that sutures needles were noted to be dull. Details related to patient harm have not been reported. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50912188 ↗MalfunctionSep 27, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910028 ↗MalfunctionSep 17, 2026Dull, Blunt
A physician reported that, during procedure needle of two ophthalmic sutures did not stick. The surgery was completed on the same day, and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50800054 ↗MalfunctionSep 10, 2026Dull, Blunt
A healthcare professional reported that, tip of an ophthalmic suture found extremely blunt that resulted in difficulty piercing. Procedure details and patient impact have not been reported. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50713130 ↗MalfunctionSep 9, 2026Dull, Blunt
Patient problems: Eye Pain
MAUDE report 50695642 ↗MalfunctionSep 2, 2026Dull, Blunt
A customer reported that during intraocular lens implantation surgery, ten ophthalmic suture needles from the same lot number were found to be blunt. The surgery was completed on the same day using the same suture. There was no patient harm. This report pertains to the first of three different lot numbers received from the same facility.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564022 ↗MalfunctionAug 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50499730 ↗MalfunctionAug 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50499729 ↗MalfunctionAug 28, 2026Break
Patient problems: Insufficient Information
MAUDE report 50499728 ↗MalfunctionAug 28, 2026Dull, Blunt
Patient problems: Insufficient Information
MAUDE report 50493524 ↗MalfunctionAug 28, 2026Dull, Blunt
Patient problems: Insufficient Information
MAUDE report 50493518 ↗MalfunctionJul 17, 2026Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY TWELVE SUTURES WERE NOTED TO BE DULL. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25854333 ↗MalfunctionJul 15, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25828772 ↗MalfunctionJul 14, 2026Dull, Blunt
A CUSTOMER REPORTED THAT NEEDLES OF OPHTHALMIC SUTURES WERE NOT SHARP. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN, AND THERE WAS NO PATIENT HEALTH IMPACT. 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 25814119 ↗MalfunctionJul 3, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE WAS NOT SHARP. THE SCHEDULED PROCEDURE WAS CATARACT SURGERY, AND THE TIMING OF THE EVENT WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY. THE DETAILS OF THE PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 25703245 ↗MalfunctionJul 1, 2026Dull, Blunt
A NURSE REPORTED THAT, FOLLOWING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE, AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE INSUFFICIENTLY SHARP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25678953 ↗MalfunctionJul 1, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE BLUNT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN THE RIGHT EYE. THE SURGERY WAS COMPLETED USING THE SAME SUTURE, AND THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 25674908 ↗MalfunctionJun 18, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE WAS BLUNT. DETAILS OF THE PROCEDURE AND THE IMPACT ON THE PATIENT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION INDICATED THAT DURING THE VITRECTOMY SURGERY IN THE RIGHT EYE, THE NEEDLE WAS BLUNT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUTURE, WITHOUT ANY IMPACT ON THE PATIENT. THIS REPORT REFERS TO CASE TWO OF A TOTAL OF TWO FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546406 ↗MalfunctionJun 15, 2026Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION THE NEEDLE OF AN OPHTHALMIC SUTURE WAS BLUNT. THE SURGERY WAS COMPLETED BY REPLACING THE NEW SUTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504198 ↗MalfunctionJun 12, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION, AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING IT WITH A NEW SUTURE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485724 ↗MalfunctionJun 8, 2026Crack; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC SUTURE WAS NEEDLE WAS BLUNT AND BROKEN. THE DETAILS OF THE PROCEDURE AND PATIENT HEALTH IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED THAT FOURTEEN SUTURES FROM THE SAME LOT WERE FOUND DEFECTIVE DURING THE CATARACT SURGERY. SURGERY WAS PERFORMED BY THE ALTERNATIVE SUTURE WITHOUT ANY PATIENT HEALTH IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25429018 ↗MalfunctionJun 8, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AFTER THE VITRECTOMY SURGERY OPHTHALMIC SUTURES WERE FOUND TO BE NOT SHARP AND SURGEON COULD NOT CLOSE THE WOUND SMOOTHLY. THE SURGERY WAS COMPLETED BY AN OLD STOCK FROM DIFFERENT LOT NUMBER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25425344 ↗MalfunctionJun 5, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE DID NOT STICK SMOOTHLY DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE SAME PRODUCT. NO PATIENT HARM HAS BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25408110 ↗
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- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- Monosof SN-3695Covidien LP · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE2 recalls3 reports
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- 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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