Clareon CCWET5 (UDI 00380652455930)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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652455930), received between May 4, 2023 and Feb 6, 2026 — classified as 3 injuries.
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 Problem3
Patient problems
- Blurred Vision2
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, PER THE SURGEON¿S OPINION, THE CAUSE OF THE EVENT WAS PRODUCT. THE LENS WAS EXCHANGED TO A NON-COMPANY IOL. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 24279155 ↗InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT REASON AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE SURPRISE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 06 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, IN SURGEON'S OPINION THE EVENT MAYBE RELATED TO INACCURATE BIOMETRY. THERE WAS NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 20178390 ↗InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION/DIFFICULTY WITH VISION, CANNOT READ WELL AND HAVING TROUBLE WITH INTERMEDIATE VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH MONOFOCAL LENS. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT WAS ONLY CORRECTABLE TO DISTANCE 20/30, INTERMEDIATE 20/40. READING JIO. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ONE OF TWO.
Patient problems: Blurred Vision
MAUDE report 16868690 ↗
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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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