Clareon CCWET6 (UDI 00380652456449)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · 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 00380652456449), received between Oct 30, 2024 and Oct 30, 2024 — classified as 1 injury.
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
Patient problems
- Blurred Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INITIAL IMPLANT PROCEDURE, LENS WAS NOT STRONG ENOUGH SO THE SURGEON SCHEDULED HIM FOR A LENS EXCHANGE WHEN HE HAD ANOTHER LENS IMPLANTED, HE WAS STILL HAD ISSUES FOCUSING ON STREET SIGNS. HIS SURGEON SCHEDULED HIM FOR A LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) PROCEDURE RIGHT EYE (OD). HIS VISION STILL WAS NOT A SHARP AS HE WANTED SO HIS SURGEON DID ANOTHER LASIK PROCEDURE. HE STILL WAS NOT HAPPY WITH THE RESULT, SO THE SURGEON DID ONE MORE LASIK TREATMENT. THE REPORTER WAS TOLD TO HAVE HIS LEFT EYE TREATED WITH IOL AND THE EYES SHOULD WORK TOGETHER. CONSUMER WAS NERVOUS TO HAVE SURGERY ON HIS LEFT EYE BECAUSE NOW, ITS THE GOOD EYE. HE WAS GOING TO HAVE A 2ND OPINION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20568891 ↗
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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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