Clareon CNA0T3 (REF CNA0T3.210)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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652398800), received between Aug 29, 2024 and Sep 22, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (3 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
- Material Discolored3
- Failure to Fold2
- Defective Component1
- Failure to Advance1
- Failure to Deliver1
- Scratched Material1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Scratched Material
A healthcare professional reported that during an intraocular lens implant procedure dirt was noticed (adherence) when implanting. An attempt was made to remove the adherent material during surgery, but as it could not be removed. Upon reviewing the footage of the positioning step, a deposit or scratch-like mark is visible before the plunger advances the lens. The lens was exchanged during the initial procedure and replaced with unspecified lens.
Patient problems: Insufficient Information
MAUDE report 50852203 ↗MalfunctionJan 7, 2026Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PLUNGER DID NOT ENGAGE IOL PROPERLY AND BENT UNDERNEATH. THE ISSUE WAS NOTICED DURING PRIMING OF THE DEVICE AND THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 23988105 ↗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 (B)(4) MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS (B)(4) OF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21928041 ↗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 CURRENTLY UNKNOWN WHETHER THESE FINDINGS WERE DISAPPEARED OR CONTINUING. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. THE LENS REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 199 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925867 ↗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 181 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925447 ↗MalfunctionAug 29, 2024Failure to Fold; Failure to Fold
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT FOLD PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20102014 ↗MalfunctionAug 29, 2024Failure to Fold; Defective Component; Failure to Fold; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC TWISTED, LENS DID NOT FOLD PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20096383 ↗MalfunctionAug 29, 2024Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENSES DIDN¿T FOLD APPROPRIATELY ALSO LENS GOT STUCK TO ROOF OF THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 20096339 ↗
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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