AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.120)Recalls & reported problems

Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant

All models of AcrySof IQ PanOptix Toric UV IOL (120)

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 00380652418546), received between Mar 26, 2021 and Feb 6, 2023 — classified as 3 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 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem3

Patient problems

Visual Disturbances3
Blurred Vision1

Recent adverse event reports

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

InjuryFeb 6, 2023Adverse 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 POOR QUALITY VISION AND PULSATION/FLICKERING IN PERIPHERY, GLARE AND DYSPHOTOPSIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL IOL.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16303144 ↗
InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE SHE CANNOT READ OUT OF LENS AND WHICH MAKE THE PATIENT TO UNABLE TO PERFORM THE DAILY LIVING ACTIVITIES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 15733520 ↗
InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED A PATIENT WITH COMPLAINTS OF SHIMMER/FLASHING WHEN SHE MOVES HER EYES AND SHE CANNOT READ AT INTERMEDIATE OR NEAR FOLLOWING INTRAOCULAR LENS IMPLANT. THE SURGEON ATTEMPTED TO RESOLVE THE PATIENTS ISSUES WITH PILOCARPINE DROPS IN THE OFFICE AS WELL AS DILATING THE EYES TO SEE IF IT WOULD HELP. A YAG LASER CAPSULOTOMY WAS PERFORMED APPROXIMATELY NINE MONTHS FOLLOWING THE INITIAL PROCEDURE. THE PATIENT IS BEING SENT OUT TO RETINA AND NEUROPHTHALMOLOGY FOR FURTHER EVALUATION OF WHY SHE IS SEEING FLASHING. THE PATIENT IS ALSO PENDING AN MRI SCAN. THERE ARE TWO RELATED REPORTS FOR THIS PATIENT. THIS REPORT ADDRESSES THE PATIENT'S RIGHT EYE, AND ANOTHER MANUFACTURER REPORT WILL BE FILED FOR THE FELLOW EYE.
Patient problems: Visual Disturbances
MAUDE report 11574653 ↗

Device details

UDI-DI	`00380652418546`
Brand	AcrySof™ IQ PanOptix™ Toric UV IOL
Model	TFAT30
Catalog no.	TFAT30.120
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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