Clareon CCWET0 (UDI 00380652405904)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 00380652405904), received between May 30, 2025 and Jan 3, 2026 — 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
- Blurred Vision2
- Visual Disturbances2
- Corneal Edema1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER CALLED TO REPORT NO DEPTH PERCEPTION OR CONTRAST WITH THIS LENS. SHE HAD BEEN UNHAPPY WITH THE LENS SINCE THE DAY OF SURGERY. SHE WAS TOLD HER VISION WOULD IMPROVE AFTER SOME HEALING TIME, BUT THIS HAD NOT HAPPENED. AS A PHOTOGRAPHER, SHE CANNOT WORK LIKE THIS. SHE HAD FALLEN TWICE. SHE SPRAINED HER RIGHT WRIST THE FIRST FALL ON (B)(6) 2025 AND BROKEN HER LEFT WRIST WITH THE SECOND FALL ON (B)(6) 2025 NEEDING SURGERY TO REPAIR THE WRIST. SHE HAD DISCUSSED THIS WITH HER SURGEON WHO ORIGINALLY SUGGESTED A MONOFOCAL LENS. THEN ON A FOLLOW UP VISIT, THEY SUGGESTED COMPANY VIVITY LENS. SHE WOULD HAVE AN EXPLANT AND HAVE A MONOFOCAL LENS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING AN EXPLANTED IOL WITH PATIENT REASON AS LOSS OF SHARP CONTRAST. CLINICAL REASON BEING CHANGING FROM COMPANY IOL TO MONOFOCAL LENS.
Patient problems: Blurred Vision; Corneal Edema; Visual Disturbances; Visual Impairment
MAUDE report 23952969 ↗InjuryMay 30, 2025Adverse 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 EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS 1 MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON WAS MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 22115195 ↗
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- 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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