AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652415064), received between May 25, 2021 and Nov 20, 2023 — classified as 5 injuries.

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

Recent adverse event reports

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

• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT EXPERIENCED VISION PROBLEMS. PATIENT WAS UNABLE TO DRIVE AT NIGHT. THE LENS WAS EXCHANGED WITH ANOTHER LENS 1 YEAR FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18168687 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR AN ANOTHER MODEL OF THE SAME DIOPTER COMPANY LENS, FROM NON TORIC TO TORIC INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17371175 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLARE WITH HEADLIGHTS, VISION DARKER THAN BEFORE, STARBURSTS. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿INTOLERABLE GLARE/HALO¿. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15630620 ↗
• InjuryJan 24, 2022Adverse 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 POOR VISION AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOUR ND HALF MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. THE PROGNOSIS WAS GOOD. NO MORE INFORMATION AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13333065 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR VISION EVEN WITH GLASSES, PATIENT WAS INCOMPATIBLE WITH LENS AND UNHAPPY WITH QUALITY OF VISION. THE IOL EXCHANGED FOR ANOTHER MODEL LENS FIVE MONTHS FOLLOWING THE INITIAL PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 11876266 ↗