Clareon CNWET0 (UDI 00380652405324)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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652405324), received between May 9, 2023 and May 8, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 Problem2
- Break1
Patient problems
- Blurred Vision1
- Dizziness1
- Headache1
- Insufficient Information1
- Pain1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2025Break; Break
A PHYSICIAN REPORTED THAT BEFORE SURGERY, THEY NOTICED HAPTIC BROKEN/TORN/MISSING. SURGERY WAS COMPLETED BY USING REPLACEMENT SAMPLE LENS ON THE SAME DAY. IT WAS NOTED AS OCCURRED BEFORE DOCKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21982996 ↗InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ADMINISTRATOR REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD POOR VISUAL ACUITY. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER NON-COMPANY LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 18108861 ↗InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION AT ALL DISTANCES, EXPERIENCED HEADACHE, DIZZINESS, PAIN, PATIENT HAD A SWOLLEN HEAD AND DIZZINESS EVERY DAY, TOOK PAINKILLERS AND MEDICINE, PATIENT HAD A PAINKILLER INJECTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Dizziness; Headache; Pain
MAUDE report 16895390 ↗
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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