Clareon CNWET0 (UDI 00380652405140)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652405140), received between Jul 11, 2025 and Mar 7, 2026 — classified as 2 injuries, 2 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision2
- Insufficient Information2
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. CLINICAL REASON BEING MENTIONED AS PSEUDOPHAKIA LEFT EYE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 24539868 ↗MalfunctionFeb 27, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24471847 ↗MalfunctionNov 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 23534227 ↗InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MONOFOCAL TORIC LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS SATISFACTION WITH VISION QUALITY, HYPEROPIC SURPRISE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 22478577 ↗
Other intraocular lens devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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