Clareon CNA0T4 (REF CNA0T4.220)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652399395), received between Jun 11, 2024 and Aug 25, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (4 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 Deliver4
- Device Difficult to Setup or Prepare3
- Defective Device1
- Failure to Fold1
- Failure to Unfold or Unwrap1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information5
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2026Product Quality Problem
A non health care professional reported with the description of faulty lens.Additional information received confirms that there was no patient contact and no impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431552 ↗MalfunctionApr 17, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TIP OF THE INTRODUCER WAS IN CONTACT WITH THE EYE, BUT THE LENS GOT STUCK ON THE EDGE. THE LENS WAS DISCARDED AND THE SPARE WAS USED WITH NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24911452 ↗MalfunctionApr 4, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL DURING SURGERY REPORTED WITH DESCRIPTION OF SLIGHTLY LEADING HAPTICS. HENCE, THEY REMOVED IT FROM THE PRE-LOADED INJECTOR AND LOADED MANUALLY THEN IMPLANTED WITHOUT ANY ISSUE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT ISSUE WITH THE BOTH LEADING HAPTICS. THE FIRST ONE WAS MORE PROMINENT THAT THE SECOND ONE. ALTHOUGH, WE¿VE PUSHED IT OUT AND LOADED ON A CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24785381 ↗MalfunctionApr 1, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS AN ISSUE WITH THE LEADING HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE EVENT OCCURRED AFTER ACTIVATING THE LOADER. THE SURGEON DID NOT WANT TO USE THE LENS AFTER NOTICING THE LEADING HAPTIC. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24756103 ↗MalfunctionJan 30, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT ONE OF THE IMPLANT LEGS (HAPTIC) DIDN'T UNFOLD PROPERLY IN THE CARTRIDGE. THEY TRIED INSERTING LENS INTO ANOTHER CARTRIDGE, BUT THAT DIDN'T CHANGE ANYTHING. THE IMPLANT WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT UNSPECIFIED REPLACEMENT LENS WAS USED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24221310 ↗MalfunctionDec 30, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL WITH A DESCRIPTION OF PROBLEM WITH LENS UNFOLDING. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT SURGERY WAS COMPLETED BY USING BACKUP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23922802 ↗MalfunctionDec 19, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED THAT WITH A DESCRIPTION OF FAILED TO DISCHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23847727 ↗MalfunctionAug 27, 2025Failure to Fold; Failure to Fold
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT LOADED CORRECTLY AND LENS FELL OUT. THE SURGERY COMPLETED SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902639 ↗MalfunctionJul 18, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT EJECT INTO THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22545766 ↗MalfunctionMar 17, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK IN THE INJECTOR. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21622596 ↗MalfunctionJun 11, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY, NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19510334 ↗
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 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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