Clareon CCW0T3 (UDI 00380652431774)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC UVA · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652431774), received between Nov 16, 2023 and Mar 10, 2026 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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
- Material Twisted/Bent1
- Scratched Material1
Patient problems
- Visual Impairment2
- Blurred Vision1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC WAS BENT UPON LOADING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24559320 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT SEVEN AND HALF DIOPTER MORE POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Visual Impairment
MAUDE report 22195757 ↗MalfunctionJun 2, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS. LENS WAS EXPLANTED IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22125503 ↗InjuryNov 16, 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, IT WAS NOTICED THAT THE PATIENT HAD DECREASED UNCORRECTED DISTANCE VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS RESIDUAL REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 18148551 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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