Clareon CCWET4 (UDI 00380652455671)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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652455671), received between Nov 11, 2022 and Aug 13, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Malposition of 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 Problem3
- Malposition of Device1
Patient problems
- Blurred Vision3
- Visual Disturbances2
- Corneal Abrasion1
- Eye Pain1
- Vitreous Floaters1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
A non health care professional reported that following an intraocular lens (IOL) implant procedure, the patient experienced blurry vision and abrasions. Clinical reason being mentioned as distorted vision with diagnosis of ERM (Epiretinal membrane). The IOL was explanted and exchanged with an unspecified monofocal lens in the secondary implant procedure. Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision; Corneal Abrasion
MAUDE report 50235678 ↗InjurySep 4, 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 REASON AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS POSITIVE DYSPHOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 MONTHS 11 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED PATIENT HAD CORNEA SWELLING AFTER LENS EXCHANGE AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: Visual Disturbances
MAUDE report 20134272 ↗InjurySep 12, 2023Malposition of Device; Malposition of Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT DISTANCE, UNCORRECTABLE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT IS RESIDUAL HYPEROPIA AND CYLINDER PERSIST AND SMALL AMOUNT OF ROTATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17728254 ↗InjuryNov 11, 2022Adverse 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 BLURRY VISION, PAIN, DARK FLOATER AND THE CLINICAL REASON FOR EXPLANT WAS DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: Blurred Vision; Eye Pain; Visual Disturbances; Vitreous Floaters
MAUDE report 15778599 ↗
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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