AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50 (REF TFAT50.200)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: 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 00380652419765), received between Apr 22, 2022 and May 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 18, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Malposition of Device1

Patient problems

Blurred Vision2
Corneal Edema1
Hemorrhage/Blood Loss/Bleeding1
Keratitis1
Visual Impairment1

Recent adverse event reports

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

InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED DECREASED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL DYSFUNCTION. ADDITIONAL INFORMATION HA BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 17030532 ↗
InjuryApr 22, 2022Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING AN CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ON DAY ONE OF POST OP, THE PATIENT PRESENTED WITH AN IATROGENIC 360 SUBCONJUNCTIVAL HEME (USED THE LENSX) PATIENT WAS UNHAPPY. VISUAL ACUITY WITH ENCOURAGEMENT WAS 20/80. THE PATIENT HAD SOME CORNEAL EDEMA, THE PUPIL WAS STILL DILATED AND THE IOL LOOKED TO BE 5-10 DEGREES OFF. REASSURED THE PATIENT AND HAD HER COME BACK ON POST OP DAY 4. THE PATIENT WAS STILL UNHAPPY WITH DIFFUSE SUPERFICIAL PUNCTATE KERATITIS (SPK). VISUAL ACUITY IS 20/60 NEAR J4 BUT ONLY WITH ENCOURAGEMENT. INTRAOCULAR PRESSURE HAS BEEN FINE IN THE LOW-MID TEENS. THE PATIENT IS NO LONGER DILATED BUT HER IOL APPEARS TO BE WELL CENTERED. THE PATIENT WAS WEARING HER OLD GLASSES WITH THE LEFT LENS REMOVED AND READING A PAMPHLET WHEN WALKED IN THE ROOM. THE PATIENT IS INDIFFERENT NOT MAD OR ANGRY BUT NOT HAPPY.
Patient problems: Blurred Vision; Corneal Edema; Hemorrhage/Blood Loss/Bleeding; Keratitis; Visual Impairment
MAUDE report 14187783 ↗

Device details

UDI-DI	`00380652419765`
Brand	AcrySof™ IQ PanOptix™ Toric UV IOL
Model	TFAT50
Catalog no.	TFAT50.200
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 18, 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