Clareon CNA0T3 (REF CNA0T3.220)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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652398824), received between Apr 29, 2025 and Sep 22, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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
- Adverse Event Without Identified Device or Use Problem2
- Material Discolored2
- Failure to Advance1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Toxic Anterior Segment Syndrome (TASS)1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that following an intraocular lens (IOL) implant procedure, the patient underwent secondary explantation procedure.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50853455 ↗MalfunctionApr 17, 2026Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PRIMING THE INJECTOR WENT TO THE SIDE OF THE LENS, PLUNGER BYPASSED THE LENS.
Patient problems: Insufficient Information
MAUDE report 24906285 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TOXIC ANTERIOR CHAMBER SYNDROME (TASS). THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 23932896 ↗MalfunctionSep 3, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THAT THE TRAILING HAPTIC FOLDER UNDERNEATH OPTIC AND STUCK DIFFICULT TO REMOVE FROM OPTIC. HOWEVER, THE SURGEON MANAGED OVERUSING IOL MANIPULATOR AND COMPLETED THE PROCEDURE ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22950636 ↗MalfunctionApr 29, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF LENS DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE IOL LOOKED BLUE IMMEDIATELY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. IT WAS UNKNOWN WHETHER THESE FINDINGS DISAPPEARED OR CONTINUED. THE LENS REMAINED IMPLANTED. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 136 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926237 ↗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 21924902 ↗
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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