Clareon CNA0T4 (REF CNA0T4.230)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652399418), received between Apr 30, 2025 and Jul 22, 2026 — classified as 1 injury, 12 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare4
- Failure to Deliver4
- Failure to Advance2
- Device Damaged by Another Device1
- Failure to Prime1
- Failure to Unfold or Unwrap1
- Inaccurate Delivery1
- Material Twisted/Bent1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 22, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 25904052 ↗MalfunctionApr 21, 2026Failure to Prime; Failure to Advance; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE REPORTED, THE INJECTOR WAS BROKEN THE PLUNGER PASSED OVER THE INTRAOCULAR LENS WHILE LOADING THE LENS, RESULTING IN TEARING OF THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. 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 24941312 ↗MalfunctionApr 1, 2026Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT DURING THE INTRODUCTION OF THE IMPLANT INTO THE PATIENT¿S EYE AN UNSPECIFIED DEFECT WAS OBSERVED. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE USING HE BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24751613 ↗MalfunctionFeb 16, 2026Failure to Advance
A PHARMACIST REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT REMAINED STUCK BEHIND THE INJECTOR. THE INCIDENT OCCURRED DURING THE PROGRESSION OF THE IMPLANT INSIDE THE EYE, AT THE LEVEL OF THE INJECTION SYSTEM. THE IMPLANT PASSED BEHIND THE INJECTION SYSTEM AT THE CARTRIDGE LEVEL, MAKING IT IMPOSSIBLE TO RETRIEVE IT. THE SURGERY WAS COMPLETED USING ANOTHER UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24344439 ↗MalfunctionDec 30, 2025Failure to Deliver; Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PISTON FAILED TO ADVANCE THE IMPLANT. THE IMPLANT REMAINED STUCK IN THE INJECTOR. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE IMPLANT REMAINED STUCK IN THE INJECTOR. THERE WAS NO IMPROPER HANDLING DURING INSERTION. THERE WAS NO OTHER SURGICAL DECISIONS THAT LED TO A DIFFERENT THERAPEUTIC APPROACH. THE SURGEON CHANGED THE IMPLANT AND INJECTOR. THE SURGERY WAS COMPLETED DURING THE SAME PROCEDURE BY USING THE SAME DIOPTER LENS.
Patient problems: Insufficient Information
MAUDE report 23922442 ↗MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS DESTROYED.
Patient problems: Insufficient Information
MAUDE report 23791189 ↗MalfunctionNov 11, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON ADVANCING THE LENS BUT DID NOT LOAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23523096 ↗MalfunctionNov 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR IMPLANTATION SURGERY, THE IMPLANT COULD NOT BE PROPERLY POSITIONED BECAUSE THE HAPTIC OF THE IMPLANT REMAINED STRAIGHT UPON EXITING THE INJECTOR INSTEAD OF CURVING.
Patient problems: Insufficient Information
MAUDE report 23521845 ↗MalfunctionOct 28, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS STUCK TO THE OPTIC. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LEADING HAPTIC WHICH IS STUCK TO THE POSTERIOR OPTIC FACE. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405991 ↗MalfunctionAug 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT TRAILING HAPTIC WAS FOLDED WRONGLY WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22701384 ↗InjuryJul 24, 2025Inaccurate Delivery; Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AN IOL WAS NOT IMPLANTED PLACEMENT FAILURE. SURGEON FORGOT THAT T4 IMPLANTS ABOVE 21.5D HAD A 2.6 MM TIP, SO THE IMPLANT CAME COMPLETELY OUT OF THE INCISION, NO PATIENT IMPACT. THEN ENLARGED THE INCISION AND THE BACK-UP IMPLANT WAS PLACED.
Patient problems: Insufficient Information
MAUDE report 22601482 ↗MalfunctionMay 26, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED WITH A DESCRIPTION OF LENS DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED BY USING UNSPECIFIED REPLACEMENT IOL.
Patient problems: Insufficient Information
MAUDE report 22084935 ↗MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, THE LENS GO STUCK I THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE BACK UP LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 21933543 ↗
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 18, 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