Clareon CNW0T4 (UDI 00380652410045)Recalls & reported problems

Alcon Laboratories, Inc. · CLAREON BLF TORIC · Class 3 · Implant

All models of Clareon (1142)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652410045), received between Mar 14, 2025 and Feb 12, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Scratched Material2
Device Dislodged or Dislocated1
Material Twisted/Bent1

Patient problems

Insufficient Information2
Blurred Vision1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionFeb 12, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH ON THE IOL OPTIC WAS OBSERVED AFTER IMPLANTATION, THE SURGEON EXPLANTED THE LENS AND REPLACED IT WITH A NEW IOL.
Patient problems: Insufficient Information
MAUDE report 24320855 ↗
MalfunctionJun 5, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED SCRATCH OR MARK ON OPTIC. THE LENS HAS CENTRAL SPLINES THAT INTERFERE WITH THE VISUAL AXIS. THE LENS WAS REMOVED AND ANOTHER LENS WAS IMPLANTED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152502 ↗
InjuryMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) PROCEDURE, THE LENS WAS ROTATED IN PATIENT AFTER DAY ONE OF POST OPERATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT 32 YEAR PATIENT WHO HAD HIGH MYOPIA WAS IMPLANTED WITH THE COMPANY LENS. DURING DAY 1 POST OPERATION EXPERIENCED BLURRY NEAR AND DISTANCE VISION. NO CORNEAL EDEMA FOUND. THE SURGEON EXPLAINED PATIENT ABOUT HIS EYE BEING ABNORMALLY LARGE AND TOLD HIM TO COME BACK AFTER 2 WEEKS FOR IOL ROTATION. CAME BACK AFTER WEEK AND WAS OK WITH WEARING GLASSES. POST OP 17 DAYS THE LENS WAS ROTATED 54 DEGREES AND AFTER ONE MONTH 55 DEGREES. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IN PATIENTS OPINION LENS CONTRIBUTED THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 21952084 ↗
MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BENT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS LENS WAS REMOVED DURING INITIAL PROCEDURE BECAUSE BACK HAPTIC WAS STUCK TO ITSELF.
Patient problems: Insufficient Information
MAUDE report 21605476 ↗

Device details

UDI-DI	`00380652410045`
Brand	Clareon
Model	CNW0T4
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 21, 2022

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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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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