Clareon CNWET5 (UDI 00380652467230)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 00380652467230), received between Jan 13, 2026 and Jan 13, 2026 — classified as 1 injury.
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
- Material Split, Cut or Torn1
- Optical Decentration1
Patient problems
- Insufficient Information1
- 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.
InjuryJan 13, 2026Optical Decentration; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE FIRST LENS HAD TO BE EXPLANTED BECAUSE IT WAS DAMAGED BY THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE, DURING INITIAL SURGERY, IOL DID NOT CENTER INITIALLY IN THE OR BUT WITH ROTATION LOOKED CENTERED. NO DAMAGE TO THE IOL WAS NOTED AT THAT TIME. THERE WAS A SLIGHT DECENTRATION POST OPERATIVE DAY ONE AND WAS WORSEN, SO A REPOSITIONING OR EXCHANGE WAS BROKEN. INTRAOPERATIVELY IT WAS NOTED THAT THERE WAS A TEAR IN THE IOL AT ONE OPTIC/HAPTIC JUNCTION SO THE IOL WAS REMOVED IN ONE PIECE AND EXCHANGED WITH A NEW IOL WITHOUT COMPLICATIONS. IT WAS REPORTED THAT THE IOL WAS IN GOOD POSITION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24051656 ↗
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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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