Clareon CCWET5 (UDI 00380652455992)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
- 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 00380652455992), received between Jun 27, 2023 and Dec 1, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 Problem3
- Scratched Material1
Patient problems
- Blurred Vision2
- Visual Impairment2
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED BLURRY VISION AND MYOPIA. THE LENS WAS EXPLANTED FOLLOWING THE INITIAL PROCEDURE WITH ATIOL LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PRODUCT DID NOT CAUSED OR CONTRIBUTED THE EVENT. IN SURGEON OPINION MYOPIC SURPRISE RELATED TO REFRACTIVE SURPRISE. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 23681052 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 23680050 ↗InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH FOGGY AND BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER MONOFOCAL LENS MODEL 2 MONTHS 10 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS IOL POWER OFF, LEFT WITH ASTIGMATISM. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT COMPLAINING OF NOT SEEING AS WELL AS HE HAD HOPED AND HAS TO TILT HEAD BACK AND DISTANCE VISION CLEARS A LITTLE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19679355 ↗MalfunctionJun 27, 2023Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED LENS WAS SCRATCHED. THE LENS WAS IMPLANTED AND REMOVED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17209084 ↗
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 13, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page