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AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U210)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
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 00380652415545), received between Nov 7, 2021 and Apr 17, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Deformation” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Material Deformation1
  • Material Opacification1

Patient problems

  • Blurred Vision2
  • Visual Impairment2
  • Dry Eye(s)1
  • Halo1
  • Vitreous Floaters1

Recent adverse event reports

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

  • InjuryApr 17, 2025Material Opacification; Material Deformation; Material Opacification; Material Deformation

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLISTENINGS AND FEELS LIKE HIS VISION IS GETTING WORSE. THERE WAS SOME SORT OF HAZINESS OVER THE POSTERIOR ASPECT OF THE LENS. THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE AND POSSIBLY VITRECTOMY FOR FLOATERS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment; Vitreous Floaters

    MAUDE report 21856298 ↗
  • InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BAD HALOS, NO GOOD NEAR VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT AVOIDS NIGHT DRIVING, SIGNAL NIGHT VISION ISSUES, ONCOMING CAR LIGHTS ARE VERY PROBLEMATIC AND ¿DISCO¿ LIGHTS, POOR DISTANCE VISION.

    Patient problems: Blurred Vision; Dry Eye(s); Halo

    MAUDE report 13042928 ↗
  • InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A NON HEALTH CARE PROFESSIONAL REPORTED AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION THE PATIENT COULD NOT SEE WELL AND THE LENS WAS EXPLANTED. THE CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Blurred Vision; Visual Impairment

    MAUDE report 12757253 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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