Clareon CNW0T6 (UDI 00380652411172)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652411172), received between May 6, 2024 and Feb 14, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blurred Vision1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 14, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) EXPLANTED WITH UNKNOWN ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24340723 ↗InjuryJul 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT REASON AS BLURRY DISTANCE VISION AND CLINICAL REASON FOR EXPLANT BEING MYOPIC OUTCOME AND IOL ROTATED OFF AXIS. THE IOL WAS EXPLANTED AND EXCHANGED FOR A SAME MODEL COMPANY LENS WITH A DIFFERENT DIOPTER FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions; Visual Impairment
MAUDE report 22555702 ↗MalfunctionMar 18, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A BLACK LINE WAS SEEN ON THE SURFACE OF THE IOL WHEN THE IOL WAS INSERTED INTO THE EYE. THE SCRATCH OR DIRT COULD NOT BE REMOVED AFTER CLEANING THE FRONT AND BACK OF THE OPTICAL PART WITH IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED AS IT WAS, THE LENS STILL REMAINS IN THE PATIENTS EYE. THE INJECTOR AND CARTRIDGE USED ARE BEING CHECKED AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633961 ↗MalfunctionMay 6, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRACKED TWICE ON THE HAPTIC AND STRAIGHT THROUGH THE OPTIC. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE INITIAL PROCEDURE ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19247506 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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 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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