A.C.S® (Alcon Closure System) 8065198001Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type CU-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. surgical suture is a fine black nylon eye suture with a double-armed needle, used for closing the eye in cataract and other eye surgery. The 61 reports mostly describe needles arriving blunt or breaking, sometimes during surgery, with the thread separating from the needle or the suture snapping mid-procedure. Two reports involved injuries. No recalls name this device.
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
- 62
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00380651980013), received between Oct 13, 2023 and Sep 18, 2026 — classified as 2 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (42 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, Blunt42
- Break32
- Material Discolored4
- Material Split, Cut or Torn2
- Packaging Problem2
- Crack1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Insufficient Information17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break; Material Discolored
A physician reported that three ophthalmic sutures from the same batch were opened to check their strength, and they broke easily during surgery. Two sutures appeared different in color from normal and, therefore, were not used on a patient. The surgery was completed using another suture without any issues. Procedure details were not reported. 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 50816116 ↗MalfunctionApr 3, 2026Crack
A CUSTOMER REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE TIP WAS SEPARATED AND DETACHED FROM THE THREAD. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT REPORTED EVENT OCCURRED BEFORE THE SURGERY AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780836 ↗MalfunctionFeb 20, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, OPHTHALMIC SUTURES WERE FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE SUTURES WITHOUT ANY PATIENT HARM. THIS FILE PERTAINS TO RIGHT EYE OF THE PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399230 ↗MalfunctionFeb 20, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, OPHTHALMIC SUTURES WERE FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE SUTURES WITHOUT ANY PATIENT HARM. THIS FILE PERTAINS TO LEFT EYE OF THE PATIENT INVOLVED IN THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399159 ↗MalfunctionFeb 10, 2026Break
A NURSE REPORTED THAT BEFORE SURGERY AFTER OPENING THE PACKAGE AND PLACING AN OPHTHALMIC SUTURE INTO THE HOLDER, IT BROKE IMMEDIATELY AND COULD NOT BE USED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT 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 24301942 ↗MalfunctionJan 20, 2026Dull, Blunt
THE CUSTOMER REPORTED THAT OPHTHALMIC SUTURE NEEDLES WAS FOUND TO BLUNT. DETAILS OF THE PROCEDURE AND ANY PATIENT IMPACT HAVE NOT YET BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24114350 ↗MalfunctionJan 8, 2026Break
A GOVERNMENT AGENCY REPORTED THAT DURING A SURGERY AN OPHTHALMIC SUTURE WAS USED TO SUTURE THE PATIENT'S WOUND, WHERE THE SUTURE HAD BROKEN. THE SURGERY WAS SCHEDULED FOR A TREATMENT OF PTERYGIUM. THE SURGERY WAS COMPLETED ON THE SAME DAY POST REPLACING THE SUTURE WITH ANOTHER OF THE SAME LOT NUMBER. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. CURRENT CONDITION OF THE PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24001247 ↗MalfunctionNov 19, 2025Break; Break
A CUSTOMER REPORTED THAT DURING SURGERY, THE OPHTHALMIC SUTURE BROKE EASILY AND APPEARED THINNER AND OF LOWER QUALITY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 23591406 ↗MalfunctionOct 30, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERIES, THE OPHTHALMIC SUTURE NEEDLES FROM THE SAME BATCH WERE FOUND TO BE BLUNT WHEN STITCHING THE CORNEA. THE SURGERIES WERE COMPLETED USING AN ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23422931 ↗MalfunctionOct 23, 2025Break; Material Split, Cut or Torn; Break; Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY THE OPHTHALMIC SUTURE WAS THINNER AND HAD BROKEN EASILY. THERE WAS CONTACT WITH THE PATIENT BUT THERE WAS NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367310 ↗MalfunctionSep 12, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC SUTURE HAD BLUNT NEEDLE. DETAILS OF SURGERY AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23035209 ↗MalfunctionAug 29, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SUTURE NEEDLE WAS BLUNT AND NOT SHARP ENOUGH. THE PATIENT HAD NO BLEEDING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE ONE OF FOUR REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 22920861 ↗MalfunctionAug 28, 2025Packaging Problem; Packaging Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THREE OPHTHALMIC SUTURES FROM DIFFERENT LOTS WERE FOUND TO BE PACKED IN DIFFERENT PACKAGES WITH VARYING SUTURE THICKNESS. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A DIFFERENT SUTURE. PATIENT IMPACT HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22914208 ↗MalfunctionAug 28, 2025Packaging Problem; Packaging Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THREE OPHTHALMIC SUTURES FROM DIFFERENT LOTS WERE FOUND TO BE PACKED IN DIFFERENT PACKAGES WITH VARYING SUTURE THICKNESS. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A DIFFERENT SUTURE. PATIENT IMPACT HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22914205 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CORNEAL SUTURING AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE NOT SHARP ENOUGH. THE SURGEON PUSHED THE SUTURE THROUGH TWICE AND ANOTHER SUTURE WAS CHOSEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE. THIS IS THREE OF FOUR REPORTS FORM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 22872156 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CORNEAL SUTURING AN OPHTHALMIC SUTURE NEEDLE WAS FOUND TO BE NOT SHARP ENOUGH. THE SURGEON PUSHED THE SUTURE THROUGH TWICE AND ANOTHER SUTURE WAS CHOSEN. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE. THIS IS TWO OF FOUR REPORTS FORM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 22872155 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC SUTURE NEEDLES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22870779 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC SUTURE NEEDLES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22870725 ↗MalfunctionJul 11, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE WAS BLUNT AND DID NOT CUT THROUGH THE CORNEA WHEN SUTURING DURING SURGERY. SURGERY WAS COMPLETED AFTER REPLACING PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE TWO OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478110 ↗MalfunctionJul 11, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT FOUR OPHTHALMIC SUTURES FROM THE SAME LOT WERE BLUNT AND DID NOT CUT THROUGH THE CORNEA WHEN SUTURING DURING SURGERY. SURGERY WAS COMPLETED AFTER REPLACING PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE TWO OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22478108 ↗MalfunctionJun 23, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT, DURING SURGERY THE OPHTHALMIC NEEDLES WERE FOUND DULL. THE SURGERY WAS COMPLETED BY USING ANOTHER SUTURE NEEDLE. THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22306216 ↗MalfunctionJun 10, 2025Dull, Blunt; Dull, Blunt
ADDITIONAL INFORMATION IS RECEIVED INDICATED THAT, ON OCCASION, OPHTHALMIC NEEDLES DID NOT ALLOW COMPLETION OF ALL EIGHT STITCHES WITHOUT APPLYING PRESSURE. THE SURGEON NOTED THAT AFTER PASSING THE NEEDLE TWICE, INCREASED PRESSURE WAS REQUIRED FOR THE REMAINING STITCHES. THE NEEDLE WAS NOT DULL BUT LACKED OPTIMAL SHARPNESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22176628 ↗MalfunctionMay 21, 2025Break; Material Discolored; Break; Material Discolored
ADDITIONAL INFORMATION RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER SUTURE WITH NO IMPACT ON PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22061809 ↗MalfunctionMay 21, 2025Break; Material Discolored; Break; Material Discolored
ADDITIONAL INFORMATION RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER SUTURE WITH NO IMPACT ON PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22061802 ↗MalfunctionMay 7, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING KERATOPLASTY SURGERY, THREE OPHTHALMIC SUTURE FROM THE SAME BATCH WAS TORN. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21975004 ↗
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- McKesson S931BXMckesson Medical-Surgical Inc. · Suture, Nonabsorbable, Synthetic, Polyamide2 recalls2 reports
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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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