AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652414920), received between Apr 28, 2021 and May 10, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Defective Device” (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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED AT ALL DISTANCES. CONSUMER STATED SHE HAS TRIED MULTIPLE DROPS AND SHE HAS BEEN ON GLASSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16908791 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED DISTANCE VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 14306468 ↗
• InjuryAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS, GLARE AND HAD COMPLAINTS OF HAZY VISION. THE PATIENT WAS UNABLE TO ADAPT MULTIFOCAL LENS. THE MULTIFOCAL LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH MONO FOCAL LENS 14 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS MUCH HAPPIER WITH MONO FOCAL LENS. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12358071 ↗
• InjuryJun 11, 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. THE IOL WAS EXCHANGED THREE AND A HALF MONTHS LATER FOR ANOTHER LENS MODEL

  Patient problems: Visual Impairment

  MAUDE report 11982054 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED LIGHTS INSIDE EYES ESPECIALLY WHEN READING AND LIGHT SEEMS TO BOUNCES OFF THE PAGES, FLICKERING AND GLARE. THE IOL WAS EXCHANGED FIVE MONTHS FOLLOWING THE INITIAL PROCEDURE FOR ANOTHER LENS MODEL.

  Patient problems: Visual Disturbances

  MAUDE report 11894060 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED LIGHTS INSIDE EYES ESPECIALLY WHEN READING AND LIGHT SEEMS TO BOUNCES OFF THE PAGES, FLICKERING AND GLARE. THE LENS WAS EXCHANGED IN THE SECONDARY PROCEDURE WITH THE NEW LENS. THERE ARE 2 MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE REPLACEMENT LENS WAS USED. SURGERY WAS PERFORMED FOR IOL EXCHANGE.

  Patient problems: Visual Impairment

  MAUDE report 11893625 ↗
• InjuryApr 28, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS PRESENTED WITH VACUOLES AND 3 PLUS PIGMENT. THE IOL WAS EXCHANGED FOR THE SAME MODEL AND POWER 5 WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11742019 ↗