AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.180)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing and blue light filtering foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix Toric Trifocal IOL (165)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652390484), received between Jun 30, 2021 and Dec 13, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1
- Material Opacification1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2023Material Opacification; Material Opacification
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, NOTICED LENS OPACIFICATION. SURGEON PLANS TO EXPLANT THE RIGHT EYE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18317082 ↗MalfunctionJun 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, FOREIGN SUBSTANCES WERE SEEN UNDER A MICROSCOPE FOR THE LEFT EYE. INTRAOCULAR LENS WAS REMOVED BY CUTTING WITH SCISSORS AND THE SAME DIOPTER OF LENS WERE IMPLANTED. THE OPERATION WAS COMPLETED AND NO REPORTED THE PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12095661 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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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