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AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.145)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
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 00380652357623), received between May 24, 2021 and Mar 25, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Device Contamination with Chemical or Other Material1

Patient problems

  • Blurred Vision2
  • Visual Impairment2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Eye Pain1
  • Inflammation1
  • Visual Disturbances1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 25, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS(IOL) THE PATIENT EXPERIENCED -0.75 MYOPIA. THE PATIENT HAD SECONDARY CATARACT AND YAG CAPSULECTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT EXPERIENCED GLARE. ADDITIONAL INFORMATION RECEIVED STATING THE PATIENT EXPERIENCED HALOS AND FLASHES AS A MAIN FLASH SPOT WITH TWELVE POINTS AROUND THIS FOCUS AT NIGHT. ADDITIONAL INFORMATION RECEIVED STATING THE PATIENT HAD THREAD IN THE EYE AND REMOVED IN A SECONDARY PROCEDURE.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Eye Pain; Inflammation; Visual Disturbances; Visual Impairment

    MAUDE report 13903743 ↗
  • InjuryAug 11, 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 UNEXPLAINED MYOPIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 12306163 ↗
  • InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS NO SPECIFIC REFRACTION ISSUE. THE PATIENT'S VISUAL ACUITY WAS POOR. THE PHYSICIAN SUGGESTED TO WATCH THE PATIENT'S PROGRESS, BUT THE REPLACEMENT SURGERY WAS PROCEEDED BECAUSE THE PATIENT'S STATUS WAS NOT IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Blurred Vision

    MAUDE report 11870783 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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