AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.215)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
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652390552), received between Mar 13, 2022 and Apr 12, 2023 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (2 reports).
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 Problem2
- Crack2
- Material Opacification1
Patient problems
- Blurred Vision2
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 12, 2023Crack; Crack
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PHYSICIAN NOTICED A SQUARE TEAR AT 12-1 O¿CLOCK MIDPERIPHERAL IN OPTICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THE CRACK RUNS IN L SHAPE, PATIENT VISION IS NOT BOTHERED BY IT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16724236 ↗InjuryMar 9, 2023Material Opacification; Material Opacification
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS IS STILL INSIDE THE PATIENT EYE AND NO EXPLANTATION TOOK PLACE.
Patient problems: Blurred Vision; Insufficient Information
MAUDE report 16511458 ↗InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PROVIDED AS POOR VISUAL ACUITY, UNABLE TO REFRACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 14652524 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SUPPLY CHAIN MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AT ALL DISTANCES. THE IOL EXCHANGED FOR ANOTHER LENS 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. THE CLINICAL REASON FOR LENS EXPLANT WAS REPORTED AS INCORRECT TORIC IOL POWER/IOL WAS USED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 14522016 ↗MalfunctionMar 13, 2022Crack; Crack
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CRACK IN IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13752653 ↗
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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