Clareon CNWET0 (UDI 00380652405409)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · 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 00380652405409), received between Jan 12, 2023 and Jul 26, 2024 — classified as 2 injuries.
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 Problem2
Patient problems
- Halo1
- Nausea1
- Posterior Capsule Opacification1
- Visual Disturbances1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AFTER IMPLANTATION OF IOL, FOUND A POSTERIOR CAPSULE RUPTURE. THE LENS DISLOCATED INTO THE VITREOUS CAVITY WITHOUT BEING ABLE TO RESETTLE IN THE CAPSULAR BAG DUE TO ITS LONG-TERM INSTABILITY. IT WAS FURTHER DECIDED TO REMOVE THE LENS. THE LENS WAS EXTRACTED BY CUTTING AND SUBSEQUENTLY REPLACED WITH COMPANY MULTIPIECE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IT WAS BECAUSE OF SURGICAL COMPLICATION THE LENS HAD TO BE EXPLANTED.
Patient problems: Posterior Capsule Opacification
MAUDE report 19837846 ↗InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STATED THAT SHE CAN¿T SEE OUT OF LEFT EYE. GLASSES RX WAS GIVEN BUT MAKES NAUSEAS. THE PATIENT WAS GIVEN A TRIAL CONTACT LENS TO CORRECT ASTIGMATISM BUT CAN¿T SEE TO DRIVE AT NIGHT AND IT DOESN¿T FULLY CORRECT THE VISION. PATIENT ALSO EXPERIENCED HALOS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; Nausea; Visual Disturbances
MAUDE report 16146281 ↗
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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