Clareon CNA0T5 (REF CNA0T5.215)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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652399913), received between Jun 30, 2025 and Jul 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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
- Device Difficult to Setup or Prepare4
- Activation Failure1
- Failure to Deliver1
- Failure to Fold1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Failure to Deliver; Activation Failure
Patient problems: Insufficient Information
MAUDE report 50085270 ↗MalfunctionJul 10, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE FAULTY WHEN TAKEN OUT FOR THE PROCEDURE. IT WAS ALSO STATED THAT WOUND ASSIST INSERTIONS, BUT IOL CAME OUT OF THE INCISION. THERE WAS NO IMPACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788919 ↗MalfunctionJan 2, 2026Failure to Fold
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS LOADING PROBLEM. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23946282 ↗MalfunctionNov 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT HAPTIC WAS DAMAGED OR JAMMED IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23671739 ↗MalfunctionAug 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22872891 ↗MalfunctionJun 30, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THERE WAS A PLACEMENT FAILURE. THE FAILURE OCCURRED DURING SURGERY. IT WAS DESCRIBED AS BAD INJECTION INTO THE EYE. THE PATIENT WAS IMPLANTED WITH THE BACK-UP LENS. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357440 ↗
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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