A.C.S (Alcon Closure System)Recalls & reported problems across all models
Alcon Laboratories, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 226
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 18 models of A.C.S (Alcon Closure System) by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 226 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2022 and Sep 30, 2026 — classified as 18 injuries, 208 malfunctions.
The most frequently reported specific device problem is “Break” (134 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported A.C.S (Alcon Closure System) problems
Device problems
- Break134
- Dull, Blunt88
- Material Split, Cut or Torn14
- Material Discolored12
- Adverse Event Without Identified Device or Use Problem8
- Crack5
- Packaging Problem5
- Unsealed Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions134
- Insufficient Information81
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Red Eye(s)5
- Hyperemia4
- Conjunctivitis3
- Corneal Edema3
- Eye Pain3
A.C.S (Alcon Closure System) models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- A.C.S® (Alcon Closure System) 8065698001Suture, Nonabsorbable, Synthetic, Polyamide73 reports
- A.C.S® (Alcon Closure System) 8065198001Suture, Nonabsorbable, Synthetic, Polyamide62 reports
- A.C.S® (Alcon Closure System) 8065193001Suture, Nonabsorbable, Synthetic, Polyamide46 reports
- A.C.S® (Alcon Closure System) 8065192101Suture, Nonabsorbable, Synthetic, Polyamide8 reports
- A.C.S® (Alcon Closure System) 8065692101Suture, Nonabsorbable, Synthetic, Polyamide8 reports
- A.C.S® (Alcon Closure System) 8065208001Suture, Nonabsorbable, Synthetic, Polyamide7 reports
- A.C.S® (Alcon Closure System) 8065710401Suture, Nonabsorbable, Synthetic, Polyamide4 reports
- A.C.S® (Alcon Closure System) 8065307901Suture, Nonabsorbable, Synthetic, Polypropylene3 reports
- A.C.S® (Alcon Closure System) 8065710001Suture, Nonabsorbable, Synthetic, Polyamide3 reports
- A.C.S® (Alcon Closure System) 8065198201Suture, Nonabsorbable, Synthetic, Polyamide2 reports
- A.C.S® (Alcon Closure System) 8065202001Suture, Nonabsorbable, Synthetic, Polyamide2 reports
- A.C.S® (Alcon Closure System) 8065215201Suture, Nonabsorbable, Synthetic, Polyester2 reports
- A.C.S® (Alcon Closure System) 8065184601Suture, Nonabsorbable, Silk1 report
- A.C.S® (Alcon Closure System) 8065192001Suture, Nonabsorbable, Synthetic, Polyamide1 report
- A.C.S® (Alcon Closure System) 8065195601Suture, Nonabsorbable, Silk1 report
- A.C.S® (Alcon Closure System) 8065198101Suture, Nonabsorbable, Synthetic, Polyamide1 report
- A.C.S® (Alcon Closure System) 8065198501Suture, Nonabsorbable, Synthetic, Polyamide1 report
- A.C.S® (Alcon Closure System) 8065712101Suture, Nonabsorbable, Synthetic, Polyamide1 report
Recent A.C.S (Alcon Closure System) adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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