AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U235)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 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 00380652415590), received between Dec 1, 2021 and Jan 7, 2022 — 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 Disturbances2
- Visual Impairment2
- Halo1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2022Adverse 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 VISION WAS WORSE THAN BEFORE SURGERY AND ALSO HAD DYSPHOTOPSIA. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 6 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT. THE PATIENT ALSO EXPERIENCED HALOS, GLARE AND POOR VISION. THE CONTRIBUTORY CAUSE OF THE EVENT WAS LENS.
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 13193242 ↗InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED GLARE SENSITIVITY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE THREE MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 13093610 ↗InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED AFTER AN INTRAOCULAR LENS WAS IMPLANTED, THE PATIENT VISION WAS WORSE. THE LENS WAS EXCHANGED FOR ANOTHER LENS SIX MONTH AFTER INITIAL IMPLANTATION IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS GIVEN AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT EXPERIENCED GLARE AND WAS NOT HOSPITALIZED FOR ANY OF THE EVENTS. THE PROGNOSIS WAS GOOD.
Patient problems: Visual Impairment
MAUDE report 12909229 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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