A.C.S® (Alcon Closure System), PAIR-PAK II® 8065304901Recalls & reported problems
Alcon Laboratories, Inc. · Suture - Needle Type AUM-5, SC-5,Blue Polypropylene(PPN), Suture Size 10-0, Suture Length 12, Double Armed · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380653049015), received between Dec 17, 2021 and Aug 13, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Break
A customer reported that the before the cataract surgery, ophthalmic suture broke upon opening the package. Patient details were not reported. Surgery has been completed on the same day by using the alternative product. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50233084 ↗MalfunctionJul 3, 2026Break
A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC SUTURE WAS USED DURING PHACOEMULSIFICATION AND ASPIRATION COMBINED WITH SCLERAL-SUTURED INTRAOCULAR LENS IMPLANTATION IN THE RIGHT EYE. DURING THE PROCEDURE, TWO SUTURES FROM THE SAME BATCH RUPTURED UNDER ROUTINE TENSION DURING TIGHTENING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER SWITCHING TO AN ALTERNATIVE SUTURE. THE OPERATION TIME WAS PROLONGED DUE TO THE SUTURE RUPTURES. 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 25704617 ↗MalfunctionFeb 18, 2026Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE WAS BROKEN DURING THE WOUND CLOSURE OF CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377438 ↗MalfunctionJan 22, 2026Break
A NURSE REPORTED THAT BEFORE SURGERY OPHTHALMIC SUTURE WAS FOUND BROKEN WHEN OPENED. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24143652 ↗MalfunctionNov 26, 2025Break; Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE BROKEN VERY EASILY DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23653771 ↗MalfunctionSep 8, 2025Break; Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE WAS BROKE BEFORE CATARACT SURGERY. THE ISSUE WAS RESOLVED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22993966 ↗MalfunctionSep 3, 2025Break; Break
A PHYSICIAN REPORTED THAT AN OPHTHALMIC SUTURE WAS BROKEN BEFORE CATARACT SURGERY. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22952523 ↗MalfunctionNov 11, 2024Break; Break
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC SUTURE WAS BROKEN. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20652888 ↗MalfunctionApr 17, 2024Break; Break
A NURSE REPORTED THAT BEFORE CATARCT SURGERY, AN OPHTHALMIC SUTURE WAS BROKEN. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19127271 ↗MalfunctionDec 29, 2023Break; Break
A GOVERNMENT AGENCY REPORTED THAT DURING TRABECULECTOMY SURGERY FOR PATIENTS WITH GLAUCOMA, DOCTORS EXPERIENCED CHALLENGES WITH THE OPHTHALMIC SUTURE USED TO CLOSE THE SCLERAL FLAP. THIS SUTURE WAS NOTED TO HAVE POOR STRENGTH AND WAS PRONE TO BREAKAGE. FOLLOWING THE REPLACEMENT OF THE PRODUCT, THE SURGERY WAS SUCCESSFULLY COMPLETED. HOWEVER, SPECIFIC DETAILS REGARDING ANY IMPACT ON THE PATIENTS' OUTCOMES WERE NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18417246 ↗InjuryDec 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT A SUTURE WAS USED FOR THE INTRA-OCULAR LENS (IOL) IMPLANTATION OF A CATARACT SURGERY. ON THE POST-OPERATIVE DAY ONE REVIEW, THE PHYSICIAN NOTICED THAT THE IOL DROPPED TO POSTERIOR CHAMBER AND THE SUTURE WAS TORN. THE PATIENT UNDERWENT ADDITIONAL SURGERY TO FIX IT WITH THE SUTURE, HOWEVER SUTURE WAS TORN DURING THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUTURE WITH ANOTHER ONE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13026730 ↗
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