AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.205)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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652389983), received between Oct 25, 2021 and Dec 31, 2025 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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
- Scratched Material3
- Adverse Event Without Identified Device or Use Problem1
- Failure to Advance1
- Material Deformation1
- Material Opacification1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 31, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A SURFACE DEFECT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934105 ↗MalfunctionJan 5, 2024Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,THE LENS WOULD NOT EJECT FROM THE CARTRIDGE WHILE ATTEMPTING TO IMPLANT INTO PATIENT'S EYE. PROCEDURE WAS COMPLETED USING ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451796 ↗InjuryJun 7, 2023Material Opacification; Material Opacification
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED DYSPHOTOPSIA AND POOR VISUAL ACUITY. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS IN THIS PATIENT BECAME SOLIDIFIED ABOUT 3.5 MONTHS AFTER IMPLANTATION WHEN OCULAR SURFACE, STYE, AND REFRACTIVE ERROR ISSUES WERE FULLY ADDRESSED. DESPITE CORRECTING ALL ISSUES STATED, THE PATIENT CONTINUES TO COMPLAIN OF POOR DISTANCE AND NEAR VISION, DESCRIBING IT AS ¿POOR AND UNABLE TO READ WELL DESPITE ADEQUATE LIGHTING.¿ IT¿S UNCLEAR IF IT IS THE PATIENT¿S NEUROADAPTATION OR THE IMPLANT ITSELF CAUSING THE ISSUE BUT SUSPECTING IT¿S THE DIFFRACTIVE ASPECT OF THE LENS IN THIS PATIENT¿S OPTICAL SYSTEM CAUSING A LIMITED BSCVA. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE RIGHT EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 17078162 ↗MalfunctionDec 30, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TWO SCRATCHES FOUND TO HAVE ON LENS. THE LENS WAS CUT AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16077379 ↗MalfunctionDec 20, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE IOL(INTRAOCULAR LENS) WAS IMPLANTED AND THEN REMOVED WHEN HE NOTICED 2 SCRATCHES. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16012882 ↗InjuryDec 8, 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 HAD POOR VISION. THE IOL WAS EXCHANGED IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED BY THE FACILITY THAT, PATIENT WAS NOT HOSPITALIZED AND PATIENT'S SYMPTOMS GOT RESOLVED.
Patient problems: Visual Impairment
MAUDE report 12958998 ↗MalfunctionOct 25, 2021Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCH ON LENS WAS NOTED AND THE HAPTIC WAS TWISTED. THE LENS COULD NOT BE USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12693155 ↗
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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