Clareon CNA0T4 (REF CNA0T4.090)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652399135), received between Sep 16, 2024 and Aug 10, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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
- Crack1
- Device Difficult to Setup or Prepare1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the trailing haptic was folded wrong. There was no patient contact, and the procedure was completed on the same day. Additional information was requested and received stating that the trailing haptic didn't fold correctly there was no patient contact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190114 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED ABOUT AN INTRAOCULAR LENS (IOL) STATING DURING PROCEDURE THERE WAS A PROBLEM WITH THE IOL COATING (THE IOL LOOKED BLUE) AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM SO FAR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925996 ↗MalfunctionSep 16, 2024Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED LARGE CRACK WAS CONFIRMED NEAR THE CENTER OF THE OPTIC. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20224664 ↗
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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