Clareon CNA0T3 (REF CNA0T3.225)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652398831), received between Jul 24, 2024 and May 7, 2026 — classified as 2 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (5 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 Discolored5
- Device Damaged by Another Device2
- Adverse Event Without Identified Device or Use Problem1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Deliver1
- Material Deformation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information2
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS LOADED THE TRAILING HAPTIC REMAIN STRAIGHT, THERE IS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108560 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD IMPLANTED THE COMPANY LENS AND THE PATIENT HAD EXPERIENCED PHOTOPSIA UPON LENS IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, YAG CAPSULOTOMY HAD BEEN PERFORMED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 24322082 ↗MalfunctionFeb 5, 2026Failure to Deliver
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE IMPLANT REMAINED STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24269457 ↗MalfunctionJan 16, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A BROKEN HAPTIC WAS OBSERVED, WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091893 ↗MalfunctionNov 19, 2025Failure to Advance; Scratched Material; Failure to Advance; Scratched Material
A NON-HEALTH CARE PROFESSIONAL STATED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY THE PLUNGER WENT PAST THE LENS BEFORE INSERTION INTO THE EYE, RESULTING IN THE LENS BEING SCRATCHED. SURGERY WAS COMPLETED ON THE SAME DAY SUING BACK UP LENS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23593088 ↗MalfunctionAug 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC WAS NOT PUSHED FORWARD. THERE WAS NO PATIENT INVOLVEMENT. THE SURGERY COMPLETED WITH BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22731114 ↗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 43 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21926258 ↗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 184 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925997 ↗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 59 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925205 ↗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 6 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21924969 ↗InjuryFeb 5, 2025Material Discolored; Material Deformation; Material Discolored; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATING THAT, THE PATIENT WAS LAST SEEN ON (B)(6) 2025 AT ONE WEEK POST IOL EXCHANGE. THE LENS WAS EXCHANGED WITH COMPANY SAME LENS MODEL AND DIOPTER. THE IOL WAS CLEAR, CENTERED AND APPEARED NORMAL IN APPEARANCE. THE PATIENT WAS DUE TO SEE DOCTOR AGAIN ON (B)(6) 2025 FOR FOLLOW UP.
Patient problems: Blurred Vision
MAUDE report 21311727 ↗MalfunctionJul 24, 2024Device Damaged by Another Device; Device Damaged by Another Device
A PHARMACIST REPORTED, THAT DURING SURGERY. THEY NOTICED, A FAILURE TO INSTALL BROKEN IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19818503 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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- 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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