Clareon CNW0T3 (UDI 00380652409643)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 00380652409643), received between Apr 18, 2025 and Sep 4, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver1
- Material Deformation1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS GOT STUCK IN THE INSERTER. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22961576 ↗MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE HAPTICS DID NOT LOAD PROPERLY. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22746607 ↗MalfunctionMay 12, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE LENS WAS PLACED IN THE PATIENTS EYE, THE SURGEON SAW A SMALL DEFECT IN THE LENS AND IT WAS THEN REMOVED BY THE SURGEON. THE PROCEDURE WAS COMPLETED THAT DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM (LEFT EYE) TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004443 ↗MalfunctionApr 18, 2025Product Quality Problem; Product Quality Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 21864046 ↗
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- 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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