Clareon CCWET0 (UDI 00380652405676)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652405676), received between Aug 11, 2022 and May 1, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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
- Adverse Event Without Identified Device or Use Problem2
- Crack1
- Material Split, Cut or Torn1
- No Apparent Adverse Event1
- Scratched Material1
Patient problems
- Insufficient Information4
- Blurred Vision2
- Visual Disturbances2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 1, 2026Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR IMPLANT PROCEDURE, THE LENS BEING TORN UPON IMPLANTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25054669 ↗InjuryMar 27, 2023No Apparent Adverse Event; No Apparent Adverse Event
A PHYSICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16619458 ↗MalfunctionFeb 13, 2023Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE PERIPHERALLY SCRATCHED/CRACKED. LENS WAS LEFT IN THE EYE AND NOT EXPLANTED TO REPLACE. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16361991 ↗MalfunctionDec 21, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAD A SCRATCH OR NICK IN THE CENTER PORTION OF THE VISUAL AXIS. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER ONE DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LENS HAD SCRATCHED WHILE USING COMPANY DELIVERY SYSTEM.
Patient problems: Insufficient Information
MAUDE report 16021454 ↗InjurySep 13, 2022Adverse 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, HE STILL HAD GLARE AND CANNOT SEE TO READ. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15412041 ↗InjuryAug 11, 2022Adverse 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, HE STILL HAD GLARE AND CANNOT SEE TO READ. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15209880 ↗
Other intraocular lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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