AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT60 (REF TFNT60U220)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 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652417150), received between Jan 6, 2022 and Mar 28, 2024 — classified as 3 injuries.

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2
Device Dislodged or Dislocated1

Patient problems

Visual Disturbances2
Visual Impairment2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Blurred Vision1
Fatigue1
Halo1
Nausea1
Vertigo1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

InjuryMar 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DISTORTED VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS MODEL APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS LENS DISPLACED. ADDITIONAL INFORMATION AND STATED THAT SLIGHTLY DISPLACED IOL DUE TO LOOSE ZONULES AND DYSPHOTOPSIA.
Patient problems: Visual Disturbances
MAUDE report 19001415 ↗
InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), SHE HAD VERY POOR VISION, BLURRY, FOGGY, NO CLARITY, EXTREME LIGHT SENSITIVITY, EQUILIBRIUM IMBALANCE, LIGHT HEADED, NAUSEA AND OCULAR MIGRAINES. SHE WAS HAVING EYE PRESSURE PROBLEMS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH A NON COMPANY LENS THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Nausea; Vertigo; Visual Impairment
MAUDE report 15731418 ↗
InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PURCHASING PERSON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS INTOLERANCE TO GLARE AND HALO, ADVERSELY AFFECTING THE DAILY LIVING ACTIVITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Fatigue; Halo; Visual Disturbances; Visual Impairment
MAUDE report 13175643 ↗

Device details

UDI-DI	`00380652417150`
Brand	AcrySof® IQ PanOptix® Toric Trifocal IOL
Model	TFNT60
Catalog no.	TFNT60U220
Company	Alcon Laboratories, Inc.
Product code	MFK · Lens, multifocal intraocular
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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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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