Clareon SY60WF (UDI 00380652251686)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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652251686), received between Dec 23, 2025 and Dec 31, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver2
- Device Dislodged or Dislocated1
- Inaccurate Delivery1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS COULD NOT GET INTO THE EYE COMPLETELY. ADDITIONAL INFORMATION RECEIVED AND STATED, THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A BACKUP LENS OF SAME MODEL AND DIOPTER. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932675 ↗MalfunctionDec 23, 2025Failure to Deliver; Inaccurate Delivery; Device Dislodged or Dislocated; Failure to Deliver; Inaccurate Delivery; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT REMAINED STUCK IN THE CARTRIDGE ALSO IN THE INCISION. A BACKUP LENS OF SAME MODEL AND DIOPTER WAS USED TO COMPLETE THE PROCEDURE ON THE SAME DAY AND THERE WERE NO CONSEQUENCES OBSERVED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877310 ↗
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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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