Clareon CNA0T4 (REF CNA0T4.260)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 00380652399470), received between Apr 21, 2025 and Sep 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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 Prepare2
- Failure to Deliver2
- Material Deformation1
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.
MalfunctionSep 28, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, lens trailing haptic was stuck in the wound, incision was small for the device to enter. The lens was removed during the initial procedure. The procedure was completed on the same day using the backup lens.
Patient problems: Insufficient Information
MAUDE report 50921267 ↗MalfunctionAug 30, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50514714 ↗MalfunctionAug 27, 2026Material Deformation
A nurse reported that the lens was damaged and was not implanted.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50474341 ↗MalfunctionAug 7, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION THAT, THE LENS STUCK IN THE INJECTOR. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22736226 ↗MalfunctionApr 21, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21873441 ↗
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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