AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652415484), received between Jul 14, 2021 and Jul 20, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Opacification” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Material Opacification; Material Opacification

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE AND HALOS AND VISUAL DISTORTION. HENCE THE LES WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS ASTHENOPIA. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS UNABLE TO PERFORM NORMAL ACTIVITIES DUE TO POOR VISUAL ACUITY. THE LENS WAS ALSO OPACIFIED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Eye Pain; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17358614 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR BEST CORRECTED VISUAL ACUITY AND INTOLERABLE ASTHENOPIA. THE SURGEON INDICATED OVER CORRECTION OF 1 DIOPTER OF CYLINDER, THEREFORE THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 15451158 ↗
• InjuryFeb 24, 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 WAS NOT HAPPY WITH THE IOL. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT INITIALLY, THE CONSUMER WAS EXTREMELY PLEASED, BUT DISTANCE SIGHT HAS DETERIORATED A LOT OVER TIME. THE PATIENT FELT THAT HER VISION HAS GONE BACK TO WHERE IT WAS BEFORE SURGERY. SHE COMPLAINED TO DOCTOR AND WAS NOT HAPPY WITH HIS EXPLANATIONS. SHE HAS TO WEAR GLASSES FOR DISTANCE, NOT MY AIM AT ALL, WHILE READING AND MID VISION WAS VERY GOOD. SHE WOULD HAVE RATHER THE OPPOSITE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT SHE CAN SEE VERY WELL TO READ BUT CAN NOT SEE WELL AT DISTANCE. SHE STATES SHE WAS HAVING PROBLEMS TO DRIVE AND COULD NOT SEE STREET SIGNS.

  Patient problems: Visual Impairment

  MAUDE report 13590208 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTIVE SURPRISE AND BLURRED VISION. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12494872 ↗
• InjurySep 14, 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 LEFT EYE.

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

  MAUDE report 12468146 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF, ANISOMETROPIA, INTOLERABLE HALOS AROUND LIGHTS. THE LENS WAS EXCHANGED FOR A TWO DIOPTER DIFFERENCE OF POWER WITH A DIFFERENT LENS MODEL. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12167331 ↗