AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50 (REF TFAT50.215)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix Toric UV IOL (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419796), received between Mar 9, 2021 and Nov 29, 2023 — classified as 4 injuries.
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
Patient problems
- Blurred Vision2
- Dry Eye(s)1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT SUFFERED FROM INTENSE BRIGHTNESS AND GLARE. DESPITE UNDERGOING MRI SCANS FOR THE BRAIN AND EYES, WHICH YIELDED NO ABNORMALITIES, AND RECEIVING TREATMENT IN THE FORM OF EYE DROPS AND GLASSES, THE PATIENT'S CONDITION HAS NOT IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 18226048 ↗InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION FOR DISTANCE. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14496210 ↗InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) DUE TO THE PATIENT BEING UNHAPPY WITH RESULTS AND NO IMPROVEMENT WITH VISUAL ACUITY. THE PATIENT REPORTED "VISION IS WORSE." THE IOL WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD MEIBOMIAN GLAND DYSFUNCTION. FURTHER INFORMATION WAS REQUESTED; HOWEVER, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Dry Eye(s); Visual Impairment
MAUDE report 12111423 ↗InjuryMar 9, 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 EXPERIENCED UNCLEAR VISION. THE IOL ROTATED AFTER IMPLANTATION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATES THE PATIENT HAS FULLY RECOVERED WITHOUT FURTHER CONCERN.
Patient problems: Blurred Vision
MAUDE report 11444442 ↗
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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