Clareon SY60WF (UDI 00380652251389)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380652251389), received between Apr 23, 2023 and Sep 18, 2026 — classified as 1 injury, 13 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (5 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
- Scratched Material5
- Break2
- Defective Device2
- Material Split, Cut or Torn2
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Eject1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions3
- Visual Disturbances1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Split, Cut or Torn
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, Lens optic was broken. The surgery was completed on the same day.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50819305 ↗MalfunctionMay 22, 2026Scratched Material
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, UPON INSERTION SCRATCH WAS OBSERVED ON THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUES TED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25254362 ↗MalfunctionMar 16, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN FOLDING THE LENS, THE FRONT HAPTIC DID NOT FOLD INTO THE LENS. THE LENS WAS REMOVED FROM THE INJECTOR AND WOULD NOT OPEN TO ATTEMPT TO REFOLD, SO A NEW LENS WAS ACQUIRED. THERE WAS NO PATIENT HARM. 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 24604999 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSITIVE DYSPHOTOPSIA . THE IOL WAS EXCHANGED FOR NON-COMPANY LENS MODEL 7 MONTHS AND 26 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 23463881 ↗MalfunctionJul 2, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT LENS HAD SCRATCH OR MARK OM OPTIC AND THE LENS WAS REMOVED FROM THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22383789 ↗MalfunctionApr 18, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ONE SIDE HAPTIC TORN IN THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21865078 ↗MalfunctionDec 10, 2024Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS STUCK INSIDE OF WAGON WHEEL WHEN THE IOL WAS BEING INSERTED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.
Patient problems: Insufficient Information
MAUDE report 20890392 ↗MalfunctionOct 30, 2024Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED, THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DEFORMED OR ASYMMETRIC. AND THE LENS OPTIC WAS BROKEN, CRACKED, SPLIT OR TORN. THE LENS WAS DEFORMED. AND HAD APPEARED TO BE SMALL TEARS OR RIPPLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20566714 ↗MalfunctionSep 19, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEEP SCRATCH WAS NOTICED IN THE PERIPHERY OF THE IOL. IT WAS UNSURE IF IOL OR CARTRIDGE RELATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 6.
Patient problems: Insufficient Information
MAUDE report 20256376 ↗MalfunctionJul 16, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS REMOVED AND REPLACED WITH BACKUP LENS DURING THE INITIAL PROCEDURE AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19752595 ↗MalfunctionMay 7, 2024Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED WHEN IMPLANTED. THERE WAS PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19257850 ↗MalfunctionJan 30, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18606994 ↗MalfunctionMay 19, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT LENS HAVING SCRATCHES OR CRACKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS STILL IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 16960336 ↗MalfunctionApr 23, 2023Break; Break
A PURCHASING COORDINATOR REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL BROKE IN HALF. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16792869 ↗
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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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