Clareon™ CNWTT3 (UDI 00380652468480)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652468480), received between May 19, 2023 and May 26, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Malposition of Device1
- Scratched Material1
Patient problems
- Visual Impairment2
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Edema1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FOUND IT TOO HARD TO DRIVE AT NIGHT. CLINICAL REASON BEING MENTIONED AS SURGEON CHANGED DIFFRACTIVE LENS TO NON DIFFRACTIVE MONOFOCAL LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 25278716 ↗MalfunctionJul 1, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED AND LENS DAMAGE BY COMPANY HANDPIECE INJECTOR· THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 22372610 ↗InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD EXTREMELY POOR VISION AND POOR VISUAL OUTCOME. ALSO, THERE WAS DECREASE IN BOTH DISTANCE AND NEAR VISION SINCE SURGERY. STATED VISION WAS BETTER PRIOR TO CATARACT SURGERY. THE LENS WAS EXCHANGED WITH COMPANY ANOTHER MODEL IOL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS PATIENT UNABLE TO TOLERATE IOL. THE PATIENT HAD PERSISTENT CORNEAL EDEMA FOLLOWING IOL EXCHANGE. THE PATIENT'S ISSUE WAS RESOLVING. IN THE SURGEON'S OPINION PRODUCT CONTRIBUTED TO EVENT.
Patient problems: Blurred Vision; Corneal Edema; Visual Impairment
MAUDE report 20748440 ↗InjuryMay 19, 2023Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS DECENTERED. THE IOL EXCHANGED IN A SECONDARY PROCEDURE WITH MONOFOCAL IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, POSTERIOR CAPSULAR TEAR LED TO DECENTERING OF IOL.
Patient problems: Capsular Bag Tear
MAUDE report 16962036 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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