Clareon CNW0T3 (UDI 00380652409551)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652409551), received between May 16, 2025 and Jul 3, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material2
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO HAVE A FAULTY TRAILING HAPTIC AT INSERTION AND PHYSICIAN REMOVED AND REPLACED. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704217 ↗MalfunctionApr 16, 2026Material Deformation
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24893263 ↗MalfunctionMay 16, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER IMPLANTING THE LENS IN THE PATIENT'S EYE, THE SURGEON NOTICED SCRATCHES ON THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY. HOWEVER, THE SURGEON AGAIN NOTICED SCRATCHES ON THE SECOND LENS AFTER IMPLANTATION. HENCE THE SECOND LENS WAS ALSO EXPLANTED AND REPLACED WITH THE THIRD LENS SUCCESSFULLY DURING THE SAME PROCEDURE. THERE WAS NO PATIENT IMPACT. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036887 ↗MalfunctionMay 16, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER IMPLANTING THE LENS IN THE PATIENT'S EYE, THE SURGEON NOTICED SCRATCHES ON THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME SURGERY. HOWEVER, THE SURGEON AGAIN NOTICED SCRATCHES ON THE SECOND LENS AFTER IMPLANTATION. HENCE THE SECOND LENS WAS ALSO EXPLANTED AND REPLACED WITH THE THIRD LENS SUCCESSFULLY DURING THE SAME PROCEDURE. THERE WAS NO PATIENT IMPACT. THERE ARE TWO FILES ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036872 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- 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 13, 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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