Clareon CNA0T4 (REF CNA0T4.245)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 00380652399449), received between Nov 21, 2024 and Sep 25, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver2
- Device Difficult to Setup or Prepare1
- Failure to Eject1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received stating there has been no visual impact to patients at all.There are three Medical Device Reports associated with this report. This is 22 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899131 ↗MalfunctionSep 8, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the haptics of the lens was stuck on the plunger injector while pressing the speed control lever. the lens was already dislodged from the injector. The surgery was completed and had to open the spare lens with the same diopter. There was no patient contact and no patient harm.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 50672151 ↗MalfunctionApr 22, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS DID NOT LOAD PROPERLY AND IT GOT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24952570 ↗MalfunctionOct 15, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, LENS WAS STUCK IN THE INJECTOR. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300401 ↗MalfunctionNov 21, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) PROCEDURE, THE LENS BLOCKED IN INCISION DURING INJECTION (HIGH DIOPTER OF THE LENS). THE LENS WAS REMOVED WITH FORCEPS AND THE SURGERY WAS COMPLETED IN THE SAME PROCEDURE WITH NON-PRELOADED BACKUP IMPLANT WITH NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748139 ↗
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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