Clareon™ CNWTT3 (UDI 00380652468350)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652468350), received between Mar 10, 2025 and Oct 23, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Insufficient Information1
- Macular Edema1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2025Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT WAS DISSATISFIED WITH THEIR VISION, DESCRIBING IT AS BUBBLY AND REPORTING FLOATERS. CLINICAL REASON BEING MENTIONED AS CYSTOID MACULAR EDEMA POST CATARACT SURGERY. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL INTRAOCULAR LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Macular Edema; Visual Impairment; Vitreous Floaters
MAUDE report 23367605 ↗MalfunctionMar 10, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, THE DOCTOR IMPLANTED THE LENS INTO THE EYE, AND NOTICED THAT THERE WAS A SCRATCH AT THE OPTIC OF THE LENS. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21562446 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 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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