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AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U195)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 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652416047), received between Jul 23, 2021 and May 11, 2022 — classified as 2 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Dislodged or Dislocated1
  • Failure to Advance1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Blurred Vision1
  • Capsular Bag Tear1
  • Swelling/ Edema1
  • Visual Disturbances1
  • Visual Impairment1

Recent adverse event reports

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

  • InjuryMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    A MATERIALS MANGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNCOMFORTABLE, CAN NOT SEE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT REPORTING IOL WAS PLACED INTO THE CAPSULAR BAG. POSTOP THE IOL WAS SLIGHTLY DECENTERED LIKELY SECONDARY TO CAPSULAR RUPTURE OR ZONULAR WEAKNESS. PATIENT WAS UNHAPPY WITH VISION FROM DECENTERED IOL. THERE WAS NO PATIENT HARM.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Capsular Bag Tear

    MAUDE report 14354835 ↗
  • MalfunctionFeb 14, 2022Failure to Advance; Failure to Advance

    A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON LOADED THE LENS UPSIDE DOWN. HE CUT THE LENS OUT AND REPLACED WITH THE SAME MODEL AND POWER. THE PATIENT HAD MILD CORNEAL SWELLING BUT OTHERWISE LOOKED GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THAT THE PATIENT SYMPTOM'S HAS BEEN RESOLVED AND THERE IS NO HARM OCCURRED TO THE PATIENT.

    Patient problems: Swelling/ Edema

    MAUDE report 13520590 ↗
  • InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CONSUMER REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED VISION WAS NOT CLEAR. THE PATIENT VISITED A DOCTOR. THE DOCTOR MADE ADJUSTMENTS TO PATIENT IOL AND AFTER THAT PATIENT SEES LINES AT NIGHT WHILE DRIVING. THE PATIENT REPORTED THE SAME ISSUE WITH THE DOCTOR AND DOCTOR PRESCRIBED UNKNOWN EYE DROPS BUT THE CONSUMER REFUSES TO USE THE EYE DROPS. NO MORE FURTHER INFORMATION WAS AVAILABLE.

    Patient problems: Visual Disturbances; Visual Impairment

    MAUDE report 12216777 ↗

Other Lens, multifocal intraocular devices

All Lens, multifocal intraocular devices →

Sources and updates

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