Clareon CNWET4 (UDI 00380652466967)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652466967), received between Dec 4, 2025 and Dec 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL ROTATED POST- OPERATIVELY. PATIENT HAD MORE INDUCED ASTIGMATISM POST-SURGERY. THE LENSES ROTATED DAY ONE BY 19 DEGREE AND RE-ROTATED. CURRENT VISION WAS POOR AS PATIENT ALSO HAD A CORNEAL ABRASION FROM POOR EXTENDED DROP USAGE. THE PATIENT WAS TAKEN BACK TO THEATRE TO ROTATE THE LENS.
Patient problems: Visual Impairment
MAUDE report 23716794 ↗
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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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