AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.170)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Trifocal intraocular lenses is an ultraviolet absorbing and blue light filtering foldable multifocal IOL · Class 3 · Implant
All models of AcrySof IQ PanOptix Trifocal IOL (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652357678), received between Jul 15, 2021 and Oct 6, 2023 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective 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. 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 Problem4
- Defective Device1
Patient problems
- Halo2
- Visual Disturbances2
- Insufficient Information1
- Itching Sensation1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CONSUMER'S EYES HAVE BEEN ITCHING EVER SINCE. THE PATIENT IS VERY REACTIVE TO ALL PRODUCTS DERIVED FROM CORN AND NEEDS TO KNOW IF ANY CORN DERIVED MATERIALS ARE USED IN THE MANUFACTURING OF THESE LENSES. THE PATIENT DID NOT GET RELIEF FROM KETOTIFEN EYEDROPS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Itching Sensation
MAUDE report 17884069 ↗InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED HALOS AND GLARE EFFECT AND WAS UNABLE TO ADAPT TO THE DYSPHOTOPSIA. THE IOL WAS REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE WITH NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Halo; Visual Disturbances
MAUDE report 16634067 ↗InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS FACING SEVERE GLARE AND HALOS 24/7 AND THEY WERE WORST AT NIGHT. THE LENS WAS REPLACED WITH A NON-COMPANY LENS. THERE WAS NO PATIENT HARM AFTER LENS EXCHANGE.
Patient problems: Halo; Visual Disturbances
MAUDE report 16634003 ↗MalfunctionDec 20, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD A DEFECT AND IT WAS EXPLANTED AND ANOTHER LENS WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16012965 ↗InjuryJul 15, 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 WAS UNABLE TO ADAPT TO THE MULTIFOCAL IOL AND USING READERS FOR CLOSE UP ACTIVITIES. APPROXIMATELY WITHIN TWO MONTHS THE IOL WAS EXCHANGED FOR A MONOFOCAL IOL IN A SECONDARY PROCEDURE.
Patient problems: Visual Impairment
MAUDE report 12172679 ↗
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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