Clareon CCWET3 (UDI 00380652455404)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 00380652455404), received between May 8, 2025 and May 8, 2025 — 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
- Insufficient Information1
- Posterior Capsule Opacification1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND STATED, THE PATIENT EXPERIENCED POOR QUALITY VISION AND SUBJECTIVE VISUAL DISTURBANCE, WHICH WERE IMPACTING ACTIVITIES OF DAILY LIVING. TWO WEEK POST OPERATION, THE PATIENT COMPLAINS OF STRAINED VISION IN THE DISTANCE MORE NOTICEABLE IF EYES ARE DRY. CONTINUED PREDNISOLONE AND KETOROLAC AS DIRECTED. THREE WEEKS POST OPERATION, THE PATIENT COMPLAINS OF STRAINED AND BLURRY VISION WHILE DRIVING. THE PATIENT STATES NO IMPROVEMENT IN STRAIN WITH ARTIFICIAL TEARS. THE PATIENT HAD MYOPIC SHIFT, AND CONTINUED PREDNISOLONE AND KETOROLAC AS DIRECTED, REFRACTION M (UNSPECIFIED) FOR DRIVING (TEMPORARY). DISCUSSED POSSIBLE LASIK ENHANCEMENT IN FUTURE. ELEVEN WEEKS POST OPERATION, THE PATIENT COMPLAINS OF DIFFICULTY WITH DISTANCE VISION AND INTERMEDIATE VISION. THE PATIENT THINKS POSSIBLE SLIGHT IMPROVEMENT WITH DISTANCE SINCE HAVING PUNCTAL PLUGS AND USING ARTIFICIAL TEARS. ON (B)(6) 2024 THE PATIENT REFERRED FOR EVALUATION OF LASIC/ PHOTOREFRACTIVE KERATECTOMY (PRK), POST CATARACT SURGERY THE PATIENT COMPLAINS OF BLURRED VISION IN DISTANCE AND NEAR. THE PATIENT HAD POSTERIOR CAPSULAR OPACIFICATION (PCO). THE PATIENT WAS NOT SATISFIED WITH OVERALL VISION AFTE
Patient problems: Blurred Vision; Insufficient Information; Posterior Capsule Opacification; Visual Impairment
MAUDE report 21984288 ↗
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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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