Clareon CNWET0 (UDI 00380652405171)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652405171), received between Nov 24, 2023 and May 20, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Defective 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. 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 Problem2
- Defective Device1
- Failure to Deliver1
- Optical Decentration1
- Scratched Material1
Patient problems
- Blurred Vision2
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, LENS STUCK IN THE CARTRIDGE AND DID NOT ENGAGE WITH PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25227968 ↗MalfunctionDec 8, 2025Scratched Material; Scratched Material
A NURSE REPORTED WITH A DESCRIPTION OF LENS WAS SCRATCH IN CENTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735872 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING THAT LENS WAS EXCHANGED WITH COMPANY ANOTHER MODEL LENS. PATIENT'S ISSUE WAS RESOLVED. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 22750263 ↗MalfunctionDec 12, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT THEY HAVE A FAULTY LENS AND IT WAS NOT USED. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE SURGERY WAS COMPLETED WITH ANOTHER LENS AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20917213 ↗InjuryOct 9, 2024Optical Decentration; Optical Decentration
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON AND CLINICAL REASON FOR EXPLANT WAS LENS NOT CENTERED. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 21 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING EXPLANTED AND REPLACED WITH NON COMPANY IOL.
Patient problems: Insufficient Information
MAUDE report 20405366 ↗InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON BEING MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXPLANTED AND EXCHANGED FOR A NON COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PATIENT SYMPTOMS HAD BEEN RESOLVED.
Patient problems: Blurred Vision
MAUDE report 18204676 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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