Clareon CNW0T3 (UDI 00380652409568)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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652409568), received between Jun 18, 2024 and Sep 4, 2026 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Defective Device1
- Device Damaged by Another Device1
- Failure to Deliver1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 4, 2026Break
A Consumer reported that during the intraocular lens (IOL) implantation surgery, the cataract lens had a rip in it and the physician had to do another slit in the eye. Physician stated the reason was unknown for the second slit.Additional information has been received stating the incision had to be enlarged to remove the lens. Small crack in haptic was caused while removing the lens. The lens was removed and replaced with same model and same diopter lens during the initial procedure. There were no further consequences occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616400 ↗MalfunctionMar 9, 2026Device Damaged by Another Device; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DIDN'T RELEASE PROPERLY DURING THE LOADING PROCESS AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE HAPTIC FLIPPED THE LENS THROUGH THE BACKSIDE PER (B)(6) WHO WAS LOADING THE LENS. THE LENS WAS DAMAGED DURING THAT INITIAL LOADING PROCESS AS IT WAS REPORTED TO ME THAT THE HAPTIC RELEASED DURING THE LOADING PHASE AND WAS UNUSABLE. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 24544163 ↗MalfunctionFeb 18, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS STUCK IN DELIVERY SYSTEM/CARTRIDGE/ IT DID NOT DEPLOY FROM THE CARTRIDGE CORRECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21396148 ↗MalfunctionAug 22, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE DOCTOR DID NOT LIKE FIT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20030639 ↗InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 06 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 19561357 ↗
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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