AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U245)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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652415088), received between Nov 24, 2021 and Nov 24, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Defective Component” (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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Defective Component1
Patient problems
- Visual Disturbances2
- Blurred Vision1
- Halo1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2022Adverse 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 IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. THE IOL HAS BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT IS DIFFICULTY IN SEEING, GLARES AND HALOS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 15863849 ↗InjuryDec 30, 2021Defective Component; Defective Component
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE CLINICAL REASON FOR EXPLANT WAS DIFFRACTIVE LENS ISSUE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 41 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 13119485 ↗InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM, THE PROGNOSIS WAS GOOD AND THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE VISUAL ACUITY WAS EXCELLENT AND THE PATIENT WAS HAPPY.
Patient problems: Visual Disturbances
MAUDE report 12869926 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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