AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.225)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
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652390026), received between Apr 15, 2021 and Oct 8, 2024 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Crack1
- Defective Device1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Unspecified Eye / Vision Problem1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Break; Crack; Break; Crack
A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, DOCTOR NOTICED THAT THERE IS A CRACK ON THE EDGE OF THE OPTIC AND HAPTIC. WHILE IMPLANTATION, ¾ OF THE IOL WAS INSERTED WHEN SHE NOTICED THAT THERE IS A RESISTANCE TO PROCEED. SHE RETRACTED THE MONARCH TO STOP INSERTING BUT THE HAPTIC WAS DETACHED TO THE OPTIC, IT ADVANCED AND WAS FULLY INSERTED INSIDE THE EYE. DOCTOR DOESN'T HAVE IOL (INTRAOCULAR LENS) CUTTER SO SHE PROCEEDS AND FINISHED THE SURGERY AND THE OPTIC WAS INSERTED TO THE EYE SO, THEY WILL EXPLANT THE IOL IF THE PATIENT WAS READY FOR SURGERY AGAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20394407 ↗InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE OUTCOME PROBLEM. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE WITH A MONO FOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15517244 ↗InjuryDec 20, 2021Break; Break
A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. THE LENS WAS FOUND TO BE BROKEN HAPTIC WHEN OPENED. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT WAS LEFT APHAKIC AND IOL WAS IMPLANTED ON NEXT DAY AFTER THE LENS BEING ARRANGED.
Patient problems: Insufficient Information
MAUDE report 13044148 ↗MalfunctionDec 17, 2021Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE IOL DEFECTIVE NOTED. IOL WAS IMPLANTED AND THEN EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13026733 ↗InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOUR MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED FOR ANOTHER LENS DUE TO POOR VISION/TOLERANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12364380 ↗InjuryApr 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT AFTER THE INITIAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT COMPLAINED OF "POOR VISION" AND STATED A CLINICAL REASON OF "PATIENT IS NOT TOLERATING". THIS REQUIRED THE REMOVAL OF THE IOL IN A SECONDARY SURGERY AND EXCHANGED FOR A MONOFOCAL TORIC. THERE WAS NO PATIENT HARM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions; Unspecified Eye / Vision Problem
MAUDE report 11733101 ↗MalfunctionApr 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS TORE WHEN INJECTED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11673360 ↗
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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