AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.225)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 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652390576), received between May 16, 2023 and Apr 22, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Crack1
- Malposition of Device1
Patient problems
- Insufficient Information2
- Fibrosis1
- Hypopyon1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2024Break; Malposition of Device; Break; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC WAS BROKEN AT THE JUNCTION OF OPTIC. THE LENS WAS IMPLANTED. THERE WERE NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED THAT THE LENS WAS EXPLANTED BECAUSE THE LENS WAS DECENTERED AND MISALIGNED FROM THE ASTIGMATIC AXIS. THE PATIENT DID NOT SUFFER ANY INTRAOCULAR DAMAGE.
Patient problems: Insufficient Information
MAUDE report 19151529 ↗InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A MASSOTHERAPIST REPORTED THAT IMMEDIATELY AFTER INTRAOCULAR LENS (IOL) IMPLANTATION HYPOPYON AND FIBRINS WERE NOTICED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Fibrosis; Hypopyon
MAUDE report 18543871 ↗MalfunctionMay 16, 2023Crack; Crack
A NON HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD WITH A DESCRIPTION OF CRACKED INTRAOCULAR LENS (IOL) BY TECHNICIAN DURING LOADING WHICH WAS NOTED AFTER INSERTION INTO THE EYE.
Patient problems: Insufficient Information
MAUDE report 16938689 ↗
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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