AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652415057), received between Mar 15, 2021 and Nov 21, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Adverse 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 WAS UNABLE TO DRIVE AT NIGHT AND CLINICAL REASON FOR EXPLANT BEING VISION DID NOT IMPROVE AFTER 1 YEAR. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 1 OF 2.

  Patient problems: Visual Impairment

  MAUDE report 18184056 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ADMINISTRATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 10 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS FAILURE TO NEURO ADAPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14989053 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE EXPERIENCED GLARE, BLURRED VISION, STAR BURSTS AROUND LIGHTS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT OF DYSPHOTOPSIA. NO FURTHER INFORMATION WAS EXPECTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14541299 ↗
• InjuryDec 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT'S QUALITY OF VISION WAS POOR, WAXY AND COLORS OFF. THE LENS WAS EXPLANTED APPROXIMATELY SEVEN MONTH AFTER THE INITIAL PROCEDURE WITH ANOTHER LENS MODEL. THE CLINICAL REASON FOR EXPLANT WAS REPORTED AS FAILURE TO NEURO-ADAPT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13084833 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED EXPLANT OF AN INTRAOCULAR LENS (IOL) DUE TO THE PATIENT EXPERIENCING BLURRED VISION, HALOS, GLARE AND RINGS. THE IOL WAS REPLACED WITH AN ALTERNATE IOL APPROXIMATELY 1 MONTH POST IMPLANTATION. THE PATIENT'S POSTOPERATIVE VISUAL ACUITY FOLLOWING THE INITIAL PROCEDURE WAS 20/20 AND OPD (OPTICAL PATH DIFFERENCE) SCAN WAS NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12110296 ↗
• 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 COULD NOT SEE AND HAD A REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11484932 ↗