Clareon CNA0T5 (REF CNA0T5.230)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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652399944), received between Mar 26, 2025 and Apr 9, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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 Damaged by Another Device3
- Failure to Advance2
- Device Difficult to Setup or Prepare1
- Material Twisted/Bent1
Patient problems
- Insufficient Information4
- 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.
MalfunctionApr 9, 2026Device Damaged by Another Device
A PHARMACY ASSISTANT REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS NOT INSERTED INTO THE PATIENT'S EYE BECAUSE THE INJECTOR PIERCED IT, MAKING IMPLANTATION IMPOSSIBLE. THERE WAS NO PATIENT HARM. BASED ON ADDITIONAL INFORMATION RECEIVED, THE INCIDENT OCCURRED DURING THE ADVANCEMENT OF THE IMPLANT THROUGH THE INJECTION SYSTEM. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT¿S EYE. THE PROCEDURE INVOLVED THE LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A COMPANY LENS OF THE SAME MODEL, BUT WITH A POWER THAT WAS 6 DIOPTERS HIGHER THAN THE DEFECTIVE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825536 ↗MalfunctionFeb 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LEADING HAPTIC TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24242736 ↗MalfunctionJul 25, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE BLUE STYLET INTENDED TO ADVANCE THE IMPLANT WAS PASSED OVER THE LENS WITHOUT ACTUALLY DEPLOYING IT. THE SURGEON ATTEMPTED TO RETRIEVE THE IMPLANT USING FORCEPS TO PLACE IT INTO AN INJECTOR, BUT THIS WAS UNSUCCESSFUL. THE IMPLANT WAS DAMAGED DURING THE ATTEMPT AND APPEARED DARKER THAN USUAL. AS A RESULT, THE PATIENT LEFT THE PROCEDURE WITHOUT AN IMPLANTED LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22607122 ↗MalfunctionJul 25, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE BLUE STYLET INTENDED TO ADVANCE THE IMPLANT WAS PASSED OVER THE LENS WITHOUT ACTUALLY DEPLOYING IT. THE SURGEON ATTEMPTED TO RETRIEVE THE IMPLANT USING FORCEPS TO PLACE IT INTO AN INJECTOR, BUT THIS WAS UNSUCCESSFUL. THE IMPLANT WAS DAMAGED DURING THE ATTEMPT AND APPEARED DARKER THAN USUAL. AS A RESULT, THE PATIENT LEFT THE PROCEDURE WITHOUT AN IMPLANTED LENS ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22607121 ↗MalfunctionMar 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS CAME OUT WITH ANTERIOR HAPTIC STRETCHED AND TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21694844 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page