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AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50 (REF TFAT50.180)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
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419727), received between Mar 15, 2021 and Oct 4, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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
  • Failure to Align1

Patient problems

  • Visual Impairment4
  • Blurred Vision1
  • Halo1
  • Visual Disturbances1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 2 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WERE POOR VISION AND HIGH HYPEROPIC SURPRISE (+2.25). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 15538616 ↗
  • MalfunctionApr 25, 2022Failure to Align; Failure to Align

    A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD LENS DECENTERED TEMPORALLY AND POSTOP VISION (UNCORRECTED 20/60, BEST CORRECTED 20/40) REFRACTION OF +0.25 +0.75 150. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 14192358 ↗
  • InjuryMar 23, 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, ON GOING GLARE, OVERCORRECTION OF ASTIGMATISM. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

    MAUDE report 13866828 ↗
  • InjuryMar 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 EXPERIENCED TROUBLE FOCUSING, HALOS, AND WAS UNABLE TO TOLERATE THE IOL. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Halo; Visual Impairment

    MAUDE report 11484923 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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