Clareon CNWET0 (UDI 00380652405126)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 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 00380652405126), received between Feb 2, 2023 and Mar 18, 2025 — classified as 3 injuries, 1 malfunction.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- Halo2
- Insufficient Information2
- Visual Disturbances2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO DISLOCATED IOL. THE IOL WAS REPLACED WITH UNSPECIFIED MONOFOCAL LENS WITHIN A MONTH AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21631711 ↗MalfunctionOct 25, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS ROTATED IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20537238 ↗InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED THAT IOL IS HORRIBLE. ALL IMAGES BEYOND 10 FEET HAVE A SHADOW AND HALOS DURING MODERATE DAYLIGHT ARE ALMOST UNBEARABLE MAKING IT VERY DIFFICULT TO DRIVE. HYDRATING DROPS DID NOTHING. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT SPECIFICALLY DISCUSSED THE TECHNICIAN DRY EYE CONCERN WITH THE DOCTOR. HE SAID HE WASN'T REALLY CONCERNED. WE DISCUSSED AVAILABLE PRESCRIPTION STRENGTH DROPS, BUT HE INDICATED HE DIDN'T THINK THAT THE PATIENT WAS A GOOD CANDIDATE FOR THEM. THE PATIENT SENT A FOLLOW UP NOTE TO THE DOCTOR AFTER MY LAST OFFICE VISIT, AFTER WHICH THE PATIENT WAS DISCUSSED WITH THE TECHNICIAN. TECHNICIAN TOLD PATIENT TO CONTINUE THE VITAMIN SUPPLEMENTS AND PUT DROPS IN MY EYES EVERY TWO HOURS. IT MADE NO DIFFERENCE. ANOTHER TECHNICIAN RESPONDED TO MY CALL AND GAVE ME A LECTURE ON HOW THE PATIENT HAD DRY EYES. THE PATIENT STILL USE DROPS (PF FREE) OCCASIONALLY, AND TAKE THE SUPPLEMENTS FOUR TABLETS A DAILY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 16281806 ↗InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED THAT IOL IS HORRIBLE. ALL IMAGES BEYOND 10 FEET HAVE A SHADOW AND HALOS DURING MODERATE DAYLIGHT ARE ALMOST UNBEARABLE MAKING IT VERY DIFFICULT TO DRIVE. HYDRATING DROPS DID NOTHING. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT SPECIFICALLY DISCUSSED THE TECHNICIAN DRY EYE CONCERN WITH THE DOCTOR. HE SAID HE WASN'T REALLY CONCERNED. WE DISCUSSED AVAILABLE PRESCRIPTION STRENGTH DROPS, BUT HE INDICATED HE DIDN'T THINK THAT THE PATIENT WAS A GOOD CANDIDATE FOR THEM. THE PATIENT SENT A FOLLOW UP NOTE TO THE DOCTOR AFTER MY LAST OFFICE VISIT, AFTER WHICH THE PATIENT WAS DISCUSSED WITH THE TECHNICIAN. TECHNICIAN TOLD PATIENT TO CONTINUE THE VITAMIN SUPPLEMENTS AND PUT DROPS IN MY EYES EVERY TWO HOURS. IT MADE NO DIFFERENCE. ANOTHER TECHNICIAN RESPONDED TO MY CALL AND GAVE ME A LECTURE ON HOW THE PATIENT HAD DRY EYES. THE PATIENT STILL USE DROPS (PF FREE) OCCASIONALLY, AND TAKE THE SUPPLEMENTS FOUR TABLETS A DAILY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 16281804 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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