A.C.S® (Alcon Closure System) 8065307901Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type PC-9,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 8,Looped · Class 2 · Implant
All models of A.C.S (Alcon Closure System) (18)
Data updated Oct 18, 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 00380653079012), received between May 21, 2025 and Jul 30, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Break
A NURSE REPORTED THAT, BEFORE A CATARACT SURGERY, AN OPHTHALMIC SUTURE LACKED TOUGHNESS AND BROKE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE SUTURE, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666391 ↗MalfunctionJul 30, 2025Break; Break
A NURSE REPORTED THAT, BEFORE A CATARACT SURGERY, AN OPHTHALMIC SUTURE LACKED TOUGHNESS AND BROKE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE SUTURE, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666390 ↗MalfunctionMay 21, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC SUTURE WAS FOUND TO BE BROKEN, AND IT LACKED TOUGHNESS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, AND PATIENT HARM HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 22061181 ↗
Other Suture, Nonabsorbable, Synthetic, Polypropylene devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page