Clareon CNWET0 (UDI 00380652405041)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 00380652405041), received between Nov 2, 2022 and Jun 17, 2025 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Blurred Vision1
- Hemorrhage/Blood Loss/Bleeding1
- Intraocular Pressure Increased1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BOTH NEAR AND FAR BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 22234800 ↗InjuryNov 2, 2022Malposition of Device; Malposition of Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING SURGERY PATIENT EXPERIENCED HEMORRHAGING IN THE RIGHT EYE, AN ELEVATION IN INTRAOCULAR PRESSURE AND THE INTRAOCULAR LENS (IOL) NOT TO STAY IN ALIGNMENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THERE WAS BLEEDING IN THE EYE DURING SURGERY, THEY COULD NOT GET LENS IN STRAIGHT, HE HAD HIGH EYE PRESSURE. HE HAD ADDITIONAL SURGERY WHERE THEY REPOSITIONED THE LENS. THE PATIENT HAD BEEN TAKING BLOOD THINNER PRIOR TO SURGERY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Intraocular Pressure Increased
MAUDE report 15713211 ↗
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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