Clareon CNWET4 (UDI 00380652466851)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652466851), received between Jul 20, 2024 and Jun 22, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
- Material Split, Cut or Torn1
- Material Twisted/Bent1
- No Apparent Adverse Event1
Patient problems
- Insufficient Information2
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2026Material Split, Cut or Torn
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY WHILE OPENING THE BLISTER IT WAS NOTICED THAT THE LENS WAS BROKEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER LENS. THERE WAS NO PATIENT CONTACT WITH THE SUSPECTED DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588690 ↗MalfunctionFeb 18, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS WAS NOT IMPLANTED, HAPTIC ON TOP OF THE PART. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24377447 ↗InjuryJul 21, 2025No Apparent Adverse Event; No Apparent Adverse Event
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT AND CLINICAL REASON AS MECHANICAL COMPLICATION OF LENS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22555701 ↗InjuryJul 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS POSITIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Halo; Visual Disturbances
MAUDE report 19786902 ↗
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- 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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