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AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U190)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
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652416030), received between May 28, 2021 and Jun 12, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Problem3
  • Device Dislodged or Dislocated1
  • Malposition of Device1

Patient problems

  • Blurred Vision3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Clinical Signs, Symptoms or Conditions1
  • Visual Disturbances1
  • Visual Impairment1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 12, 2023Malposition of Device; Malposition of Device

    A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS ORA CALLED FOR 19.0 WHICH LEFT PATIENT NEAR SIGHTED. THE LENS ALSO ROTATED OVER 20D. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision; Visual Disturbances

    MAUDE report 17105417 ↗
  • InjuryFeb 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    A MATERIALS MANAGER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS ROTATED OFF AXIS. TRIED TO REPOSITION LENS HAPTIC WITHOUT POSSIBLY TEARING THE BAG AND THE SURGEON REMOVED AND REPLACED WITH SAME LENS MODEL. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13423965 ↗
  • InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND REPORTED THAT THE PATIENT WAS STILL VERY UPSET AND FRUSTRATED THAT THINGS HAVE NOT IMPROVED.

    Patient problems: Blurred Vision

    MAUDE report 12315497 ↗
  • InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND REPORTED, THAT THE PATIENT WAS STILL VERY UPSET. AND FRUSTRATED THAT THINGS HAVE NOT IMPROVED.

    Patient problems: Blurred Vision

    MAUDE report 12314245 ↗
  • InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT NOT HAPPY WITH VISUAL OUTCOME. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

    MAUDE report 11899948 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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