Clareon CCWET3 (UDI 00380652455145)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652455145), received between May 17, 2024 and Jul 17, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- Visual Impairment2
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON ATTEMPTED TO PLACE THE IMPLANT BUT OBSERVED THAT THE HAPTICS APPEARED FLIMSY. CONCERNED THAT THE LENS MIGHT NOT REMAIN SECURELY POSITIONED, IT WAS REMOVED AND REPLACED WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529185 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MATERIALS MANAGER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED STRAIN IN RIGHT EYE TO SEE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "NEEDED MORE ASTIGMATISM CORRECTION IN RIGHT EYE". ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 19711712 ↗InjuryMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ADDITIONAL INFORMATION RECEIVED THAT THE OPHTHALMOLOGIST SAID THAT THE PROBLEM WAS THE BRAIN ADAPTING TO THE COMPANY MODEL LENS. ADDITIONAL INFORMATION RECEIVED THAT RIGHT EYE HAS PROBLEM FROM DAY ONE. THE LONG DISTANCE VISION FOR BOTH EYES WAS EXCEPTIONAL BUT VISION WAS BLURRY WHEN DRIVING.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19341826 ↗
Other intraocular lens devices
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- 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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