Clareon CCWET0 (UDI 00380652405867)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652405867), received between Jan 10, 2023 and Mar 14, 2024 — classified as 2 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
Patient problems
- Blurred Vision1
- Corneal Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT SEEING WELL AS EXPECTED AND CANNOT READ LIKE ASSUMED. THE SURGEON HAD TOLD PATIENT COULD EITHER HAVE LENS PUT IN OR WEAR GLASSES FOR READING. PATIENT DID NOT WANT TO WEAR GLASSES OR HAVE ADDITIONAL SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18901992 ↗InjuryJan 10, 2023Defective Device; Defective Device
A SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ISSUE WITH HAPTIC WAS NOTED. CASE OF STANDARD 2.45 SMALL INCISION AT 90. WHEN SURGEON INSERTED THE LENS, NOTICED THE SUPERIOR HAPTIC WAS SMOOTHLY SEPARATED FROM THE BODY OF THE LENS FOR WHICH SURGEON NEEDED TO ENLARGE THE INCISION AND CUT THE LENS AND RE-INSERT NEW ONE WHICH CAUSED SIGNIFICANT POST-OPERATIVE CORNEAL EDEMA. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT INTRAOCULAR LENS THAT WAS INSERTED WAS DEFECTIVE. IN THEIR OPINION SUPERIOR HAPTIC WAS DEFECTIVE AND HAD PROBABLY THIN ATTACHMENT TO THE BODY OF THE LENS, SO DURING INSERTION HAPTIC WAS JUST SEPARATED FROM THE BODY DUE TO DEFECT.
Patient problems: Corneal Edema
MAUDE report 16128734 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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