Clareon SY60WF (UDI 00380652251600)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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251600), received between Jan 20, 2023 and Feb 26, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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
- Material Split, Cut or Torn2
- Scratched Material2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information4
- Capsular Bag Tear1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2026Material Split, Cut or Torn
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THEY HAD BEEN ENCOUNTERING VERY UNUSUAL ISSUES WITH THE MONOFOCAL IMPLANTS, WHICH WERE BREAKING DURING FOLDING. THEY EXPERIENCED THIS PROBLEM FOUR TIMES IN ONE WEEK. THE IMPLANTS WERE STORED IN THE PHARMACY, WHERE THE TEMPERATURE WAS MONITORED (AROUND 20¿21°C), AND ON THE DAY OF THE PROCEDURES THEY WERE KEPT IN THE OPERATING ROOM, WHERE THE TEMPERATURE WAS TYPICALLY AROUND 18°C. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24455259 ↗MalfunctionFeb 23, 2026Material Split, Cut or Torn
A PHARMACIST REPORTED THAT THE IMPLANT BROKE DURING FOLDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 4.
Patient problems: Insufficient Information
MAUDE report 24414767 ↗MalfunctionNov 20, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE WHILE LOADING INTO COMPANY CARTRIDGE THE LEADING HAPTIC WAS BROKE. THE SURGERY WAS COMPLETED WITH ANOTHER IOL. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605231 ↗MalfunctionMay 8, 2023Device Contamination with Chemical or Other Material; Scratched Material; Device Contamination with Chemical or Other Material; Scratched Material
A LEAD OPHTHALMIC NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SMALL SCUFF WAS NOTICED ON THE CENTER OF LENS. A PLASTIC FOREIGN OBJECT WAS APPARENTLY FOUND IN THE EYE AS WELL. THIS REQUIRED AN IOL EXCHANGE. THE FOREIGN OBJECT LOOKED LIKE A POST FROM THE BOTTOM HALF OF THE WAGON WHEEL CASSETTE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16884122 ↗InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CAPSULE WAS RUPTURED. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Capsular Bag Tear
MAUDE report 16493733 ↗MalfunctionJan 20, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH ON THE LENS WAS NOTED IN THE PERIPHERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16214440 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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.
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