Clareon CCWET5 (UDI 00380652456111)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652456111), received between May 29, 2023 and May 29, 2023 — classified as 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.
Most reported problems
Device problems
- Break1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2023Break; Scratched Material; Break; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT WHILE INSERTING COMPANY LENS, TRAILING HAPTIC WAS SEVERED, THE OPTIC WAS SCRATCHED. THE CASE WAS DELAYED BECAUSE THE LENS WAS INSERTED INTO THE PATIENT'S EYE BEFORE IT WAS DISCOVERED THAT THE HAPTIC WAS SEVERED. ANASTACIA WAS LONGER AND THE LENS HAD TO BE REMOVED FROM THE PATIENT'S EYE BEFORE REINSERTING A NEW LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017180 ↗
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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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