AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.120)Recalls & reported problems

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

All models of AcrySof IQ PanOptix UV IOL (28)

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 00380652429559), received between Dec 8, 2022 and May 19, 2026 — 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 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 Problem3

Patient problems

Visual Impairment2
Blurred Vision1
UGH (Uveitis Glaucoma Hyphema) Syndrome1

Recent adverse event reports

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

InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A TEAR IN THE POSTERIOR CAPSULE (PC). HOWEVER, THE SURGEON OPTED TO CONTINUE ON COURSE AND IMPLANT THE COMPANY IOL INTO THE SULCUS. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED UVEITIS GLAUCOMA HYPHEMA (UGH) SYNDROME DUE TO THE SINGLE PIECE IOL BEING IN THE SULCUS. THE IOL WAS EXCHANGED FOR UNSPECIFIED 3-PIECE MONOFOCAL IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN THE SURGEON¿S OPINION, PRODUCT DID NOT CAUSE THE EVENT, IT WAS THE LOCATION OF THE PRODUCT IN THE SULCUS THAT WAS THE ISSUE. IT WAS MENTIONED IF THERE WOULD NOT HAVE BEEN A PC TEAR/BAG BREAK, THIS WOULDN'T BE AN ISSUE, BUT THE SURGEON HAD NO CHOICE BUT TO PLACE IN SULCUS, THAT WAS THE ISSUE. THE LENS WAS EXCHANGED WITH NON-COMPANY LENS. THERE WAS NO FURTHER IMPACT TO THE PATIENT AND HEALING WELL WITH IOL IN GOOD POSITION.
Patient problems: UGH (Uveitis Glaucoma Hyphema) Syndrome
MAUDE report 25216001 ↗
InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DYSPHOTOPSIA. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 15959609 ↗
InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT'S CYLINDRICAL VALUE INCREASED POST SURGERY.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15939397 ↗

Device details

UDI-DI	`00380652429559`
Brand	AcrySof™ IQ PanOptix™ UV IOL
Model	TFAT00
Catalog no.	TFAT00.120
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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