Clareon CNWET6 (UDI 00380652467445)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652467445), received between Dec 31, 2025 and Apr 24, 2026 — classified as 1 injury, 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 Problem1
- Break1
- Failure to Deliver1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION IN THE LEFT EYE, HIS VISION WAS NOT GOOD AS EXPECTED. AT FIRST HIS VISION WAS 20/20 IN EACH EYE. HOWEVER, A WEEK AFTER SURGERY, HIS VISION DECREASED. HE EXPERIENCED MASSIVE FLOATERS WHICH WERE NOT PRESENT BEFORE THE PROCEDURE. HE WAS PRESCRIBED GLASSES WHICH HELPED HIM SEE BETTER. BASED ON ADDITIONAL INFORMATION RECEIVED ON 27-MAR-2026: THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE PATIENT REQUESTED THE EXPLANT BECAUSE HE WAS UNHAPPY WITH THE VISION. CLINICALLY, THE EXPLANT WAS INDICATED FOR THE SAME REASON, AND ADDITIONALLY BECAUSE THE PATIENT REQUIRED A HIGHER TORIC POWER.
Patient problems: Blurred Vision; Visual Impairment; Vitreous Floaters
MAUDE report 24977120 ↗MalfunctionDec 31, 2025Break; Failure to Deliver; Break; Failure to Deliver
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS OPENED AND LOADED INTO THE COMPANY INJECTOR WITH COMPANY CARTRIDGE. DURING THE PUSHING STAGE, IT WAS OBSERVED THAT THE ANTERIOR HAPTIC HAD ADHERED TO THE CARTRIDGE, PREVENTING THE INJECTOR FROM ADVANCING. THE LENS WAS REMOVED FROM THE CARTRIDGE USING FORCEPS, AND UPON INSPECTION, THE ANTERIOR HAPTIC WAS FOUND TO BE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER LENS OF THE SAME DIOPTER. THE PATIENT¿S EYE WAS NOT AFFECTED IN ANY WAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932632 ↗
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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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