Clareon CNW0T4 (UDI 00380652410151)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: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652410151), received between Aug 6, 2024 and Jul 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Opacification” (1 report).

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

Adverse Event Without Identified Device or Use Problem1
Material Opacification1
Scratched Material1

Patient problems

Blurred Vision2
Corneal Endothelial Cell Loss1
Headache1
Iritis1
No Clinical Signs, Symptoms or Conditions1
Swelling/ Edema1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 2, 2025Material Opacification; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, DURING FIRST DAY POST OPERATIVE REVIEW, THE IOL WAS FOUND TO BE NOTICEABLY OPAQUE. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT FOR ANY POSSIBLE ADVERSE EFFECTS POST OPERATIVELY. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; No Clinical Signs, Symptoms or Conditions
MAUDE report 22391695 ↗
InjuryOct 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD A POOR EXPERIENCE WITH THE SURGERY. HAS NEVER HAD TO WEAR GLASSES TO SEE TO READ, ONLY WORE GLASSES FOR DISTANCE NEEDS. WOKE UP FROM SURGERY AND WAS VERY UPSET THAT SHE COULD NO LONGER SEE TO READ OR PUT ON MAKEUP. SHE STATES SHE HAS DAILY MIGRAINES. SHE WAS ON STEROID DROPS AND REFRESH DROPS SEVERAL TIMES A DAY. SHE HAS AN APPOINTMENT TO SEE HER SURGEON TOMORROW AND WILL DISCUSS OPTIONS WITH HIM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Headache
MAUDE report 20452404 ↗
InjuryAug 6, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LINEAR DEFECT ON LENS WAS NOTICED. ADDITIONAL INFORMATION HAS BEEN RECEIVED, PATIENT HAD SUFFERED AN IRIS TEAR, ENDOTHELIAL DAMAGE WITH SWELLING, PROLONGED SURGERY AND ISSUES NOT RESOLVED, PROGNOSIS IS GOOD.
Patient problems: Corneal Endothelial Cell Loss; Iritis; Swelling/ Edema
MAUDE report 19919273 ↗

Device details

UDI-DI	`00380652410151`
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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