AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U250)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 00380652415095), received between Mar 31, 2021 and Feb 22, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Scratched 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.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem2
Scratched Material1

Patient problems

Blurred Vision3
Visual Impairment2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Corneal Abrasion1
Headache1

Recent adverse event reports

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

InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MATERIALS MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISION WAS DECREASED AND WAS WORSE SINCE SURGERY. THE IOL EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13576051 ↗
InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION WORSE, BLURRY, HEADACHE AND COMPUTER DIFFICULT. THE IOL EXPLANTED FOR ANOTHER LENS 3 MONTHS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Headache; Visual Impairment
MAUDE report 11982415 ↗
InjuryMar 31, 2021Scratched Material; Scratched Material
A CERTIFIED OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY INFERIOR VISION "LIKE LOOKING THROUGH FOGGY WATER" SINCE SURGERY. A CORNEAL ABRASION WAS RESOLVED BY POSTOPERATIVE DAY 4 WITH NO TREATMENT. POST OP SCAN SHOWS INFERIOR GLARE ON CORNEA. THE IMAGE WAS REPEATED MULTIPLE TIMES AND EVERY SCAN SHOWS GLARE IN THE SAME POSITION. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT SMALL FORCEP TEETH MARKS WERE OBSERVED ON THE LENS DURING A POSTOPERATIVE EXAMINATION. ADDITIONALLY, PIECES OF THE IOL WERE RECEIVED WHICH WOULD INDICATE THAT THE IOL WAS EXCHANGED AS PLANNED.
Patient problems: Blurred Vision; Corneal Abrasion
MAUDE report 11595533 ↗

Device details

UDI-DI	`00380652415095`
Brand	AcrySof® IQ PanOptix® Trifocal IOL
Model	TFNT00
Catalog no.	TFNT00U250
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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All Lens, multifocal intraocular devices →

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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