Clareon CNA0T3 (REF CNA0T3.230)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652398848), received between Jan 7, 2025 and Sep 25, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Discolored6
- Device Difficult to Setup or Prepare2
- Failure to Deliver2
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Failure to Unfold or Unwrap1
Patient problems
- Insufficient Information6
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Deliver
A physician reported that during an intraocular lens (IOL) implantation procedure, an attempt was made to insert the lens, but the lens did not deploy/come out normally during insertion. The IOL was subsequently removed and replaced with the same company product during initial implantation procedure. The procedure was completed on the same day without any harm to the patient. 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 50894667 ↗MalfunctionApr 10, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS COMPLETELY TWISTED AND STUCK TO THE OPTIC. THE SURGEON OPTED NOT TO IMPLANT IT DUE TO THE RISK OF CAPSULAR BAG RUPTURE IN SMALL EYES. HENCE THE BACK-UP LENS WAS USED TO COMPLETE THE PROCEDURE SMOOTHLY.
Patient problems: Insufficient Information
MAUDE report 24838720 ↗MalfunctionApr 5, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS PREPARED AS PROTOCOL WITH 0.28ML OF COMPANY VISCOELASTIC IN THE OPHTHALMIC VISCO SURGICAL DEVICE (OVD) PORT WITHIN THE CORRECT TIME FRAME. WHEN THE LENS WAS ADVANCED THE TRAILING HAPTIC WAS STRAIGHT. A BACK UP LENS WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY AND THERE WAS 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 24786714 ↗MalfunctionJan 12, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL STATED THAT DURING AN INTRAOCULAR IMPLANTATION PROCEDURE LENS WAS STUCK IN THE DELIVERY SYSTEM. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24038653 ↗MalfunctionAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS FAULTY, THE HAPTIC WENT TOP OF THE LENS.
Patient problems: Insufficient Information
MAUDE report 22911208 ↗MalfunctionMay 8, 2025Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap; Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED PROBLEMS WITH THE UNFOLDING OF THE TWO HAPTICS OF THE LENS. LENS REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21985119 ↗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 121 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21929340 ↗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 28 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926394 ↗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. THERE HAVE BEEN NO REPORTED HEALTH PROBLEMS OR HARM TO THE PATIENT. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE 224 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS 27 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925437 ↗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 17 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925219 ↗MalfunctionJan 7, 2025Material Discolored; Material Discolored
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING PATIENT WAS EXPERIENCING POOR VISION, ALSO REPORTED THERE MIGHT BE POSSIBLE PATIENT HARM.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 21090887 ↗MalfunctionJan 7, 2025Material Discolored; Material Discolored
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AS PER SURGEON POSSIBILITY OF PATIENT INJURY. ALSO STATED POSSIBLY NON SERIOUS POOR VISION DUE TO A PROBLEM ON THE SURFACE OF IOL WITH UNKNOWN CAUSALITY.
Patient problems: Insufficient Information
MAUDE report 21090208 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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