AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U105)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
- 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 00380652414807), received between Apr 30, 2021 and Jul 19, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Malposition of Device1
Patient problems
- Visual Impairment2
- Fall1
- Intraocular Pressure Increased1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ACCOUNTANT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 5 WEEKS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS MYOPIC SHIFT. ADDITIONAL INFORMATION WAS RECEIVED STATING ON POST OF DAY 7 INTRAOCULAR PRESSURE (IOP) WAS ELEVATED AT THAT VISIT TO 33. HE WAS STARTED ON BETA BLOCKER MEDICATION. AT 2 WEEKS POST OP, IOP WAS 23. AT 5 WEEKS POST OP, HE WAS HAVING SIGNIFICANT ISSUES WITH VISUAL FUNCTIONING AND HAD A FALL WITH NO SERIOUS HARM. IOP WAS NORMAL AT 16. AT THIS VISIT, PHYSICIAN MADE THE DECISION TO REPLACE THE LENS. PATIENT IS NOW SEEING 20/20 WITH NEW LENS AND IS HAPPY WITH VISION.
Patient problems: Fall; Intraocular Pressure Increased; Visual Impairment
MAUDE report 15051747 ↗InjuryApr 30, 2021Malposition of Device; Malposition of Device
A FACILITY REPRESENTATIVE REPORTED THAT AFTER THE INITIAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT COMPLAINED OF "POOR VISION" AND A CLINICAL REASON OF "POOR CENTRATION". THIS REQUIRED THE REMOVAL OF THE IOL IN A SECONDARY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 11752686 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
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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