Clareon CCWET4 (UDI 00380652455633)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652455633), received between Sep 27, 2023 and Nov 9, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Scratched Material1
Patient problems
- Blurred Vision2
- Visual Impairment2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD TROUBLE WITH READING DISTANCE. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 4 MONTH AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS PATIENT UNHAPPY WITH REFRACTIVE ERROR RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 20647242 ↗InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE VISION. CLINICAL REASON WAS MENTIONED AS INTRAOCULAR LENS POWER OFF. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL ONE MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM. AS PER THE SURGEONS OPINION, THE IOL POWER BEING OFF WAS CAUSE FOR THE EVENTS.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19202599 ↗MalfunctionSep 27, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CORNEAL CLEARING WAS DELAYED 1 DAY FROM INCREASED OPERATIVE TIME IN EYE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17824031 ↗
Other intraocular lens devices
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- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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