Clareon CCWET4 (UDI 00380652455596)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 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 00380652455596), received between Feb 13, 2023 and Dec 4, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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 Problem1
- Crack1
Patient problems
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT PATIENT HAD BLURRY VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS MECHANICAL COMPLICATIONS OF IOL. ADDITIONAL INFORMATION RECEIVED STATING THAT LENS WAS REPLACED WITH COMPANY LENS WITH DIFFERENT MODEL AND DIOPTER.
Patient problems: Blurred Vision
MAUDE report 20840779 ↗MalfunctionFeb 13, 2023Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE PERIPHERALLY SCRATCHED/CRACKED. LENS WAS LEFT IN THE EYE AND NOT EXPLANTED TO REPLACE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16361984 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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