Clareon™ CNWTT4 (UDI 00380652469067)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652469067), received between May 22, 2023 and Apr 24, 2026 — classified as 5 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Component” (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
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Defective Component1
- Scratched Material1
Patient problems
- Visual Disturbances3
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Dry Eye(s)1
- Excessive Tear Production1
- Eye Injury1
- Halo1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED HALOS AT NIGHT AND FLICKERING. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL TORIC LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS DESCRIBED AS INTOLERABLE DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Disturbances
MAUDE report 24981751 ↗MalfunctionMar 2, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING A FOLLOW-UP VISIT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH HAD BEEN NOTED ON THE OPTIC PORTION OF THE LENS. THE SURGEON CONFIRMED THAT NO FORCEPS HAD BEEN USED ON THE OPTIC PART AND HAD NO PLAN TO PERFORM AN EXCHANGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS IMPLANTED ON (B)(6) 2025 AND SCRATCH WAS NOTICED ON (B)(6) 2026. THERE WAS A PRIOR FOLLOW-UP; HOWEVER, THE PHYSICIAN WAS UNSURE WHETHER THE MARK EXISTED BEFOREHAND.
Patient problems: Insufficient Information
MAUDE report 24483292 ↗InjuryDec 12, 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, THE PATIENT WAS NOT TOLERATING GLARE, HALO. CLINICAL REASON BEING MENTIONED AS NOT NEURO NON-OPTING TO INTRAOCULAR LENS (IOL) DIFFRACTION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; Visual Disturbances
MAUDE report 20912504 ↗InjuryFeb 29, 2024Defective Component; Defective Component
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS IMPLANTED INTO PATIENT'S EYE AND NOTICED THAT LENS WAS TORN OR SCRATCHED UPON IMPLANTATION.A SKIN LESION WAS ALSO REPORTED AND SUTURED WITH 7-0 VICRYL. SUBSEQUENTLY, THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Eye Injury
MAUDE report 18808228 ↗InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CHARGE NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT WAS NOT HAPPY WITH THE VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS ASTIGMATISM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 17396191 ↗InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULDN'T SEE WELL AT ANY DISTANCE AND EYES DID NOT HEAL AS WELL AS EXPECTED. THE PATIENT HAD BLURRY VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Excessive Tear Production; Impaired Healing; Visual Disturbances; Visual Impairment
MAUDE report 16972317 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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