Clareon CNA0T4 (REF CNA0T4.180)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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652399319), received between Apr 17, 2025 and Aug 21, 2026 — classified as 7 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
- Material Discolored2
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Unfold or Unwrap1
- Inaccurate Delivery1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2026Failure to Unfold or Unwrap
A non-health care professional reported that during the intraocular lens (IOL) implantation surgery, the leading haptic stuck on posterior optic. The surgeon used an instrument to unstick the haptic and the surgery was completed. There was no patient harm.Additional information has been requested but no information is available at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372391 ↗MalfunctionJan 23, 2026Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FAILURE PLACEMENT WAS DUE TO INCORRECT DEPLOYMENT OF THE IMPLANT DURING INSERTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24161018 ↗MalfunctionMay 28, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) TRAILING HAPTIC GOT STUCK IN PLUNGER. SURGEON HAD TO USE A SECONDARY INSTRUMENT TO REMOVE HAPTIC FROM DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095781 ↗MalfunctionMay 6, 2025Failure to Advance; Failure to Advance
A PHARMACIST REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS A PROBLEM WITH THE INJECTOR, THE PLUNGER WAS NOT FACING THE IMPLANT, THE PLUNGER WAS NOT ORIENTED IN THE SAME AXIS IN THE INJECTOR, THE IMPLANT WAS AT A DIFFERENT ANGLE. HOWEVER, THE LENS WAS IMPLANTED INTO THE PATIENT'S EYE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21968702 ↗MalfunctionApr 30, 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 21933312 ↗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 55 OF 224.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21927515 ↗MalfunctionApr 17, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS NOT USED AS TRAILING HAPTIC WAS STRAIGHT ON ADVANCEMENT OF PLUNGER. LENS WAS NOT IMPLANTED. THE SURGERY WAS COMPLETED WITH UNSPECIFIED REPLACEMENT IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21854552 ↗
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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