Clareon CCW0T4 (UDI 00380652432870)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652432870), received between Oct 30, 2023 and Aug 12, 2026 — classified as 3 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Material Deformation1
- Scratched Material1
Patient problems
- Insufficient Information3
- Visual Impairment3
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Material Deformation
Patient problems: Insufficient Information
MAUDE report 50221885 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient ended more myopic than predicted. Subsequently the lens was removed and replaced with an unspecified advanced technology intraocular lens (ATIOL) in a secondary procedure. The clinical reason for explant was refractive surprise due to duanes syndrome.Additional information has been requested but is not available at the time of this report.
Patient problems: Visual Impairment
MAUDE report 50086130 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH SEVERE POSITIVE DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 28 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED. A QUESTIONNAIRE WAS RECEIVED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 24222174 ↗MalfunctionJan 3, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SIGNIFICANT SCRATCHES LARGE AND CRACK LIKE. SEASONED TECH WAS IN THE ROOM AND LENSES WERE LOADED JUST BEFORE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLIANT. THIS REPORT IS 3 OF 6.
Patient problems: Insufficient Information
MAUDE report 21066470 ↗MalfunctionOct 23, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PHYSICIAN NOTED IT WAS DEFECTIVE NOT MALUABLE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20516812 ↗InjuryOct 30, 2023Adverse 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 BLURRED VISION, CLINICAL REASON FOR EXPLANT BEING MECHANICAL COMPLICATION OF IOL WITH REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18028812 ↗
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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