AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652415040), received between Mar 22, 2021 and Jul 12, 2022 — 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.

• InjuryJul 12, 2022Adverse 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 HALOS AND DIFFICULTY IN DRIVING IN NIGHT. THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SHE HAS BEEN GIVEN GLASSES FOR NIGHT DRIVING AND HAS ALSO TRIED EYE DROPS GIVEN TO HER BY SURGEON TO HELP WITH GLARE- NOTHING IS HELPING. SHE STATES IT'S ONLY WITH NIGHT DRIVING, HER HUSBAND DOES THE DRIVING B/C GLARE IS TOO MUCH FOR HER. SURGEON STATES SHE'S NOT ABLE TO HAVE EXPLANT DUE TO HER BEING SURGICAL/PROCEDURE YAG.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14985635 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRED VISION AT DISTANCE/NEAR, GLARE, REFRACTIVE ERROR AND IOL EXCHANGE. POST IMPLANTATION AFTER 40 DAYS THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12319842 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, THE PATIENT EXPERIENCED VISION BLURRY, DYSPHOTOPSIA AND VISUAL DISTURBANCE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 1 YEAR FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS CONSUMER. THIS REPORT IS FOR THE FIRST EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12280944 ↗
• InjuryAug 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ADMINISTRATOR REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, THE PATIENT EXPERIENCED HALOS, SENSITIVITY TO LIGHT, GLARE, DYSPHOTOPSIA, BLURRY VISION AND VISUAL DISTURBANCE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 1 YEAR FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS CONSUMER. THIS REPORT IS FOR THE SECOND EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12277272 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT DID NOT HAVE IMPROVED DISTANCE OR NEAR VISION. THREE AND A HALF MONTHS AFTER INITIAL IMPLANTATION THE LENS WAS EXCHANGED FOR A DIFFERENT MODEL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11624196 ↗
• InjuryMar 22, 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 TERRIBLE VISION WITH COMPUTER DISTANCE, GLARE, HALOS. THE LENS WAS REMOVED AND REPLACED ON A SECONDARY SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11541699 ↗