AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U155)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Trifocal intraocular lenses is an ultraviolet absorbing and blue light filtering foldable multifocal IOL · Class 3 · Implant

All models of AcrySof IQ PanOptix Trifocal IOL (73)

Data updated Oct 16, 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 00380652414906), received between Aug 24, 2021 and Jan 9, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (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

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

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2
Material Deformation1

Patient problems

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

Recent adverse event reports

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

InjuryJan 9, 2025Material Deformation; Material Deformation
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH DECREASED VISUAL ACUITY. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 04 YEARS 22 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS SIGNIFICANT GLISTENINGS IN LENS WITH DECREASED VISUAL ACUITY FUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21113654 ↗
InjuryDec 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT CANNOT TOLERATE HALOS AT NIGHT, AFRAID TO DRIVE, DYSPHOTOPSIA WITH NIGHT TIME GLARE AND RINGS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE AFTER 8 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances
MAUDE report 16041516 ↗
InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IOL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE. THE IOL WAS REMOVED AND REPLACED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 12358990 ↗

Device details

UDI-DI	`00380652414906`
Brand	AcrySof® IQ PanOptix® Trifocal IOL
Model	TFNT00
Catalog no.	TFNT00U155
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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