AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT60 (REF TFNT60U165)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: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652417044), received between Jul 20, 2021 and Sep 13, 2024 — classified as 2 injuries.

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

Patient problems

Blurred Vision1
Conjunctivitis1
Halo1
Hypersensitivity/Allergic reaction1
Posterior Capsule Opacification1
Visual Disturbances1
Visual Impairment1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HYPEROPIC AND UNDERWENT LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) PROCEDURE. THE PATIENT HAD HYPEROPIC REGRESSION POST LASIK PROCEDURE AND AGAIN BACK TO HYPEROPIC. THE IOL WAS EXCHANGED FOR DIFFERENT MODEL AND DIFFERENT DIOPTER COMPANY LENS 3 YEARS 2 MONTHS 25 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. AS PER REPORTER THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, POST IMPLANTATION OF LENS, THE PATIENT HAD ALLERGIC CONJUNCTIVITIS, POSTERIOR CAPSULAR OPACIFICATION.
Patient problems: Conjunctivitis; Hypersensitivity/Allergic reaction; Posterior Capsule Opacification; Visual Impairment
MAUDE report 20212127 ↗
InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CERTIFIED OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION. THE PATIENT ALSO EXPERIENCED GLARE AND HALOS. THE LENS WAS EXCHANGED FOR ANOTHER MANUFACTURERS LENS, WITH DIFFERENT CYLINDRICAL AND SPHERICAL POWER, IN A SECONDARY PROCEDURE. THE PATIENTS ISSUES HAVE RESOLVED AND THE SURGEONS PROGNOSIS IS EXCELLENT. THIS REPORT IS FOR THE LEFT EYE. NO FOLLOW UP REQUIRED.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 12197562 ↗

Device details

UDI-DI	`00380652417044`
Brand	AcrySof® IQ PanOptix® Toric Trifocal IOL
Model	TFNT60
Catalog no.	TFNT60U165
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.

Other Lens, multifocal intraocular devices

Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
144 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
1 recall66 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
113 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
112 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
110 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
107 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
104 reports
Clareon™ CNA0T0
Alcon Laboratories, Inc. · Lens, multifocal intraocular
93 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page