Clareon SY60WF (UDI 00380652251310)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652251310), received between May 29, 2023 and Apr 10, 2026 — classified as 6 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Scratched Material2
- Entrapment of Device1
- Failure to Deliver1
- Failure to Eject1
- Material Discolored1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Break
ACCORDING TO ADDITIONAL INFORMATION RECEIVED THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE BACKUP LENS. IT WAS THE TRAILING HAPTIC THAT WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845404 ↗MalfunctionFeb 13, 2026Break; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING CALIBRATION/SETUP OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS STUCK TO THE CARTRIDGE WALL, ATTEMPTED TO PUSH THE IOL WITH A VISCOELASTIC AND PLUNGER FROM 2 SIDES, RINSE WITH A SOLUTION, WHEN TRYING MOVE THE LENS WITH PLUNGER HAPTIC BROKE OFF. THE PATIENT WAS NOT IN CONTACT WITH THE IOL AND THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. 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 24333232 ↗MalfunctionJul 15, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHILE INSERTING THE LENS INTO THE CARTRIDGE, A SCRATCH WAS OBSERVED ON THE LENS OPTIC. THE LENS WAS NOT INJECTED INTO THE PATIENT¿S EYE. THE PHYSICIAN DECIDED NOT TO PROCEED WITH THE IMPLANTATION OF THE DEFECTIVE LENS AND REPLACED IT WITH BACKUP LENS AND COMPLETED THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 22504952 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 44 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925845 ↗MalfunctionJan 3, 2024Break; Scratched Material; Break; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC BROKE OFF AND LENS HAD SCRATCHED. THE LENS APPEARED DEFECTIVE UPON PLACEMENT. PROCEDURE IS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18434261 ↗MalfunctionMay 29, 2023Entrapment of Device; Failure to Eject; Entrapment of Device; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE SURGEON HAD HARD TIME INSERTING THE INTRAOCULAR LENS INTO THE EYE. THE IOL WAS PROPERLY FOLDED AND LOADED IN TO THE CARTRIDGE NO DEFECT OR DAMAGE ON THE CARTRIDGE NEITHER ON THE UNFOLDER. THE IOL WAS PARTIALLY INSERTED IN THE EYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17016874 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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