AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652414968), received between Mar 12, 2021 and Sep 22, 2021 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EYE IRRITATION AND REDNESS, EPISCLERITIS, SECONDARY CATARACT/POSTERIOR CAPSULE OPACIFICATION, DECREASED VISION AND OCCASIONAL DISCOMFORT. THE PATIENT DISCONTINUED CONTACT LENS WEAR AND WAS PRESCRIBED WITH MEDICATIONS FOR EPISCLERITIS. THE PATIENT'S VISUAL SYMPTOMS INCLUDE TROUBLE DRIVING AT NIGHT BECAUSE OF GLARE, TROUBLE DOING NEAR WORK LIKE THREADING A NEEDLE OR READING FINE PRINT. THE PATIENT UNDERWENT YAG CAPSULOTOMY AND THE VISUAL ACUITY WAS IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Discomfort; Red Eye(s); Visual Disturbances

  MAUDE report 12515570 ↗
• InjuryApr 12, 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 POOR VISION AND WAS UNABLE TO IMPROVE VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE WHICH WAS UNEVENTFUL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 11652615 ↗
• InjuryMar 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, A PATIENT EXPERIENCED BLURRY VISION, GLARE, HALOS AND DRIVING ISSUES. THE LENS WAS REMOVED ON A SECONDARY SURGERY AND REPLACED BY ANOTHER LENS.

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

  MAUDE report 11504699 ↗
• InjuryMar 12, 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 "VERY BAD GLARE AND HALOS." THE PATIENT ALSO REPORTED "CAN'T DRIVE WELL AT WORK." THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11477858 ↗