Clareon™ CNWTT3 (UDI 00380652468428)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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652468428), received between Mar 22, 2023 and Apr 6, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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 Problem1
- Crack1
- Defective Device1
Patient problems
- Insufficient Information2
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT COULD NOT TOLERATE HALOS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER UNKNOWN MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA/ PHOTOPHOBIA WITH NIGHT DRIVING. ACCORDING TO ADDITIONAL INFORMATION RECEIVED, THE PATIENT DESCRIBED THAT SHE COULD NOT DRIVE AT NIGHT, THE HALOS WERE UNBEARABLE. THERE WAS NO FURTHER IMPACT TO THE PATIENT. THE PATIENT ISSUES WERE RESOLVED AFTER EXPLANTATION. THE SURGEON PROGNOSIS STATED DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Disturbances
MAUDE report 24791672 ↗MalfunctionJul 16, 2024Crack; Crack
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, ON (B)(6) 2024, DURING THE LENS IMPLANT, A CRACK WAS DISCOVERED ON THE EDGE OF THE LENS AND AN EXCHANGE WAS PERFORMED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19750810 ↗MalfunctionMar 22, 2023Defective Device; Defective Device
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS SEVERED UPON IMPLANTATION. THESE WERE REMOVED AND BACK-UPS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 16589150 ↗
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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