AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.200)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652390521), received between Nov 16, 2021 and Apr 2, 2025 — classified as 3 injuries, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Malposition of Device1
- Scratched Material1
Patient problems
- Insufficient Information2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Scratched Material; Scratched Material
OTHER HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS HAD A MARK AFTER SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21750174 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT BIOMETRIC DEVIATION IN THE POST-OPERATIVE PERIOD DUE TO THE FACT THAT SHE HAD UNDERGONE PREVIOUS LASER SURGERY IN ANOTHER SERVICE, USING THE HIGH-GRADE LASIK TECHNIQUE. DUE TO THE HIGH CURVATURE OF THE CORNEA, WHICH MAKES IT IMPOSSIBLE TO APPLY A NEW LASER TO TREAT THE RESIDUAL DEGREE IT WAS DECIDED TO CHANGE THE INTRAOCULAR LENS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 22 DAYS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Visual Impairment
MAUDE report 19826575 ↗InjuryFeb 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION WAS RECEIVED AS INTRAOCULAR LENSES WERE STUCK TO THE CAPSULE IN BOTH EYES DURING SURGERY, POST SURGERY PATIENT HAD DECENT VISION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16361985 ↗InjuryNov 16, 2021Malposition of Device; Malposition of Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR UCVA, BCVA DESPITE LOW REFRACTIVE ERROR. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT HAD TEMPORAL CORNEAL EDEMA AFTER EXPLANTATION. THE PATIENT ISSUE HAD BEEN RESOLVED AND THE SURGEON PROGNOSIS WAS GOOD. THE PATIENT WAS NOT HOSPITALIZED. PATIENT UNDERWENT ROTATION OF THE TORIC LENS ON (B)(6) 2021, IMPLANT WAS ROTATED APPROXIMATELY 15 DEGREES TO REDUCE 1.00 D ASTIGMATISM. ADDITIONAL INFORMATION RECEIVED STATED THAT ROTATION OF THE LENS TOOK PLACE PRIOR TO THE DECISION TO EXPLANT.
Patient problems: Corneal Edema; Visual Impairment
MAUDE report 12820584 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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