AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652390019), received between Mar 4, 2021 and Apr 30, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2025Adverse 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 HYPEROPIC SHIFT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE LENS WAS NOT REPLACED BUT IN 2024 AUTUMN PATIENT GOT 1ST ADD ON PSEUDOPHAKIC LENS IN THE LEFT EYE. THE SURGEON EXPLAINED TO PATIENT THAT WHEN THEY COVER THE RIGHT EYE (UNOPERATED EYE) THE VISION WILL BE QUANTIFIABLY OKAY. THE RIGHT EYE WAS NOW NOT OPERATED; THE SURGERY WAS SCHEDULED FOR END OF (B)(6) 2025 FOR COMPANY LENS. THE SURGEON EXPECTS THAT IF BOTH EYES HAD DIFFRACTIVE TECHNOLOGY LENS, THE NEUROADAPTATION WOULD HELP THE PATIENT. SINCE IT LOOKS LIKE NOW THAT THE OD IS SOMEHOW DISTURBS THE PATIENT TO GET USED TO THE IOL. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ADD ON PSEUDOPHAKIC LENS WAS NOT AN COMPANY PRODUCT.

  Patient problems: Visual Impairment

  MAUDE report 21936568 ↗
• MalfunctionOct 24, 2024Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A PROBLEM DURING THE INSERTION IN THE INCISION IN THE PATIENT'S RIGHT EYE. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING IMPLANT GOT STUCK IN THE CARTRIDGE AND THEN IT GOT DAMAGED WHEN SCREWED THE INJECTOR.

  Patient problems: Insufficient Information

  MAUDE report 20528222 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NO DISTANCE VISION, BLUE FOG, STAR BURST LIGHTS AT NIGHT AND HALOS. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT WAS UNABLE TO DRIVE AT NIGHT. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18765519 ↗
• 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 11 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16808274 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HALOS WHILE DRIVING AT NIGHT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo

  MAUDE report 12432855 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS WAS IMPLANTED, THE PATIENT EXPERIENCED DYPHOTOPSIA . THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 5 MONTHS AFTER INITIAL IMPLANTATION. DYSPHOTOPSIA WAS THE CLINICAL REASON GIVEN FOR THE EXPLANT .

  Patient problems: Visual Disturbances

  MAUDE report 12233188 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY THE NURSE HAD REPORTED THAT THE IOL WAS EXCHANGED FOR ONE DIOPTER DIFFERENCE OF POWER AND FROM A TORIC TO A NON-TORIC IOL.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11877734 ↗
• MalfunctionMar 4, 2021Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS POSSIBLY SCRATCHED BY THE PLUNGER FROM INSERTER. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412016 ↗