Clareon CNA0T3 (REF CNA0T3.130)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652398640), received between Feb 16, 2026 and Feb 16, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- Blurred Vision1
- Diplopia/Double Vision1
- Intraocular Pressure Increased1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Device Dislodged or Dislocated; Material Deformation
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT WAS COMPLAINING OF CLOUDY, DOUBLE IMAGES, HALO AND CONSTANT HAZE AND DIFFICULTY SEEING OUT OF THAT LEFT EYE. HOWEVER, PATIENT WAS COMPLAINING OF DECREASED VISION, HAD POSTOP SPIKE IN PRESSURE, ON CARBONIC ANHYDRASE INHIBITORS (CAIS) THREE TIMES A DAY AND OPHTHALMIC CORTICOSTEROID (TOPICAL STEROID) FOUR TIMES A DAY TO THAT LEFT EYE. VISION WAS 20/150 IN THE LEFT EYE. PINHOLE IN THAT LEFT EYE WAS 20/100 2. RE PINHOLED HIM AND FOUND HIM TO BE A POOR 20/30 3 IN THAT EYE. CONJUNCTIVA WHITE, CORNEA CLEAR; ANTERIOR CHAMBER (AC) DEEP AND CLEAR; 1+ TO 2+ NS RIGHT EYE, VITREOUS CLEAR IN THE RIGHT EYE. PUPIL WAS NOT DILATED UPON THE PATIENT'S REQUEST. LEFT EYE REVEALED THE CORNEA CLEARLY. AC DEEP AND CLEAR, PICOL PRESENT, SOME CORTICAL MATERIAL WAS IN THE PERIPHERAL PORTION OF THE CAPSULE ANTERIOR OF THE CAPSULE FROM THE 8 TO 11. THE CAPSULE WAS INTACT WITH A MINIMAL HAZE. CONTACT LENSES WERE USED. THERE WAS A SLIGHT HAZE EVEN WITH MY CONTACT LENS TO VIEW THE FOVEA OF THE LEFT EYE. OCT FINDINGS WERE FELT TO BE INSIGNIFICANT EXCEPT FOR VITREOMACULAR ADHESIONS SEEN IN BOTH EYES. ELLIPSOID LAYER NORMAL BOT
Patient problems: Blurred Vision; Diplopia/Double Vision; Intraocular Pressure Increased; Visual Disturbances; Visual Impairment
MAUDE report 24342662 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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