Clareon CCWET0 (UDI 00380652405577)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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652405577), received between Sep 20, 2023 and Jan 2, 2025 — classified as 3 injuries, 1 malfunction.
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 Problem3
- Crack1
- Scratched Material1
Patient problems
- Visual Disturbances2
- Halo1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Eye / Vision Problem1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 2, 2025Crack; Scratched Material; Crack; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOTICED TO BE SCRATCHED OR CRACKED. SURGEON THREW AWAY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21053910 ↗InjuryJul 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE IOL WAS EXPLANTED AND EXCHANGED FOR A DIFFERENT MODEL UNSPECIFIED DIOPTER COMPANY LENS FOLLOWING THE SECONDARY IMPLANT PROCEDURE.
Patient problems: Unspecified Eye / Vision Problem; Visual Disturbances
MAUDE report 19870230 ↗InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COMPLAINED THAT THE VISION WAS NOT CLEAR; PATIENT SAW FLOATERS AND LOTS OF GLARE & HALOS. THE LES WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE MECHANICAL ISSUES WITH THE IOL WERE CITED AS THE CLINICAL REASON FOR THE EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo; Visual Disturbances; Vitreous Floaters
MAUDE report 18208349 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR CONTRAST. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BEST-CORRECTED VISUAL ACUITY (BCVA) 20/30, NEAR VISUAL ACUITY IS BETTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 17782660 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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