Clareon CCWET3 (UDI 00380652455411)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 00380652455411), received between Dec 11, 2023 and Dec 11, 2023 — 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Edema1
- Intraocular Pressure Decreased1
- Visual Disturbances1
- 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 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S SYMPTOMS SHOWED SLOW GRADUAL IMPROVEMENT, BUT THEN STOPPED AS THE PATIENT DEVELOPED POSTERIOR CAPSULAR PACIFICATION (PCO). YTTRIUM-ALUMINUM-GARNET (YAG) LASER SURGERY HAS BEEN PLANNED TO OPEN UP THE CAPSULAR BAG WHICH COULD HELP THE CLOUDINESS. THE DOCTOR COULD SEE THIS HAS DEVELOPED ALONG WITH A 60 DEGREE FOLD LINE IN BAG CAUSING GLARE LINES IN PATIENT'S VISION. PRIOR TO PCO THE PATIENT NOTICED THAT IT WAS DIFFICULT TO SEE CLEAR WHILE DRIVING ON CLOUDY DAYS OR INDOORS IN DIM LIGHTING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Corneal Edema; Intraocular Pressure Decreased; Visual Disturbances; Visual Impairment
MAUDE report 18301084 ↗
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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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