Clareon CNW0T6 (UDI 00380652411165)Recalls & reported problems

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

All models of Clareon (1142)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652411165), received between Apr 27, 2023 and Dec 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Break2
Defective Device1
Material Discolored1
Material Opacification1
Scratched Material1

Patient problems

Insufficient Information3
No Clinical Signs, Symptoms or Conditions2
Visual Impairment1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 16, 2025Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGERY HAD BEEN PERFORMED AND NO FOREIGN MATERIAL HAD BEEN FOUND. HOWEVER, THE CENTER OF AN IOL HAD BEEN OBSERVED TO HAVE BECOME WHITISH DURING A SLIT LAMP EXAMINATION ON FOLLOW UP VISIT. THE WHITENESS HAD FADED DURING AN EXAMINATION ON FOLLOW UP. THERE HAD BEEN NO PLANS TO REPLACE THE IOL, AND THERE HAD BEEN NO PROBLEMS WITH THE VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23816277 ↗
MalfunctionJun 3, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PRESSING TO IMPLANT A LENS HAPTIC WAS BROKEN WITH NO PATIENT CONTACT AND THE IOL WAS CHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22138471 ↗
MalfunctionApr 25, 2025Break; Break
PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR HAPTIC BROKE. SURGEON STATED THAT THE LENS WAS NOT EXPLANTED AND FOLLOWING THE PROCEDURE PATIENT EXPERIENCED SIGNIFICANT HYPERMETROPIZATION AND THE IMPLANT DID NOT SEEM TO HAVE ROTATED.
Patient problems: Visual Impairment
MAUDE report 21909237 ↗
MalfunctionDec 6, 2024Material Opacification; Material Opacification
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THAT THE FINDING WAS OBSERVED RIGHT AFTER THE INSERTION OF THE IOL DURING THE SURGERY. THE PATIENT WAS SATISFIED WITH THE POSTOPERATIVE CONDITION. THE SURGEON DID NOT MENTION DETAILS ABOUT THE COURSE OF THE FINDING. ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED TO THE SALES REPRESENTATIVE THAT THE FINDING HAD BEEN CONTINUING BUT THERE WAS NO INFORMATION AFTER LAST FOLLOW UP.
Patient problems: Insufficient Information
MAUDE report 20873352 ↗
MalfunctionApr 27, 2023Defective Device; Scratched Material; Defective Device; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16824706 ↗

Device details

UDI-DI	`00380652411165`
Brand	Clareon
Model	CNW0T6
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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