AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652389990), received between Jun 14, 2022 and Feb 20, 2024 — classified as 4 injuries, 2 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT INTRAOCULAR LENS MOVED FORWARD LEAVING PATIENT WITH MYOPIC ERROR.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye

  MAUDE report 18744879 ↗
• MalfunctionApr 25, 2023Defective Device; Defective Device

  A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), IMPLANT PROCEDURE LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 12 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16807507 ↗
• InjuryMar 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL HAS BEEN EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS IOL GLISTENING CAUSING DECREASED VISION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Blurred Vision

  MAUDE report 16565330 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IS NOT SEEING WELL AND THE VISION IS NOT FOCUSING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE 2 OF 2. ADDITIONAL INFORMATION IS NOT EXPECTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16121438 ↗
• InjuryDec 13, 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 HAD LIGHT REFLECTIONS, HALOS AND STARBURST. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, SINCE THE FIRST DAY AFTER THE SURGERY PATIENT SEE VERY DISTURBING LIGHT RINGS AND HALOS AS WELL AS GLARE AND STARBURST AROUND LIGHT SOURCES, ESPECIALLY INTENSE IN THE DARK, E.G. STREET LAMPS, TRAFFIC LIGHT, CAR HEADLIGHTS/TAIL LIGHTS, BICYCLE LIGHTS AND OTHER LIGHT REFLECTIONS; ESPECIALLY INTENSE WITH WHITE POINT-SHAPED LIGHT SOURCES (WITHOUT OR WITH VARIFOCALS NO DIFFERENCE). THEY ARE NOT ONLY ANNOYING, BUT ALSO DANGEROUS, ESPECIALLY BY CAR TRIPS DURING THE DARK. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15967915 ↗
• MalfunctionJun 14, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ON THE LEFT SHOWS PROBABLY DUE TO THE SHOOTER TWO IMPRESSIONS, WHICH ARE OPTICALLY RELEVANT OR DISTURBING. PHYSICIAN IS NOW PLANNING TO REMOVE THIS IOL AND REPLACE IT WITH A NEW ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14685004 ↗