AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652357852), received between Nov 19, 2021 and Aug 10, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 16, 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.

• MalfunctionAug 10, 2026Failure to Deliver

  Patient problems: Insufficient Information

  MAUDE report 50192982 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  A PHYSICIAN REPORTED THAT THE PATIENT UNDERWENT CATARACT SURGERY TO LEFT EYE ON (B)(6) 2019. SUBSEQUENTLY, A YAG CAPSULOTOMY WAS PERFORMED IN THE LEFT EYE ON (B)(6) 2022. IN 2025 THE PATIENT WENT FOR THE FOLLOW UP AND UPON EXAMINATION, IT WAS OBSERVED THAT THE INTRAOCULAR LENS IN THE LEFT EYE WAS DIFFUSELY STUDDED WITH GLISTENING ACROSS THE ENTIRE OPTIC SURFACE. THIS WAS NOT LOCALIZED TO A FEW SPOTS BUT INVOLVED THE WHOLE LENS OPTIC. AS A RESULT, THE PATIENT VISION DROPPED BY ONE LINE FOR BOTH DISTANCE AND NEAR IN THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR LEFT EYE (OS).

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 23278872 ↗
• MalfunctionSep 6, 2024Defective Device; Scratched Material; Defective Device; Scratched Material

  A PHARMACIST REPORTED VIA REGULATORY AUTHORITY STATING DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED AFTER IMPLANTING INTRAOCULAR LENS (IOL), AN APPARENT IRREGULARITY IN THE OPTICS OF THE IOL IN THE CENTRAL AREA, A POSSIBLE MANUFACTURING DEFECT OR SUPERFICIAL ABRASION OF THE IOL. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154715 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT UNDERWENT A FEMTO LASIK AND THE VISION WAS +1 SPH. THE PATIENT HAS COMA IN THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE TWO COMPLAINTS ASSOCIATED WITH THE PATIENT. THIS IS 2 OF 2 FILES.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 19499124 ↗
• MalfunctionJan 8, 2024Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL DAMAGED AT THE OPTIC HAPTIC JUNCTION. THE SURGEON WAS NOT SURE OF LENS HAVING DAMAGED BEFORE LOADING OR AFTER LOADING TO THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED WITH THE SAME LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18462789 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE EXPERIENCED HUGE STARBURSTS AND SHE CANNOT DRIVE AT NIGHT ANYMORE. SHE IS ALSO EXPERIENCING HALOS WHICH ARE TERRIBLE AT NIGHT AND UNDER BRIGHT LIGHTS DURING THE DAY, SHE IS ALSO EXPERIENCING BIT OF A SHADOWING AROUND LETTERS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15416678 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, SHE WAS EXPERIENCING HUGE STARBURST AND HALOS, SHE CAN'T DRIVE AT NIGHT ANYMORE. CONSUMER DISCUSSED WITH HER SURGEON AND HER SURGEON ADVISED TO REPLACE THE IOL WITH ANOTHER BRAND. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15416284 ↗
• InjuryNov 19, 2021Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTICS GOT RUPTURED INSIDE THE CARTRIDGE. A REPLACEMENT OF THE LENS WAS MADE. ADDITIONAL INFORMATION WAS RECEIVED BY CONSUMER THAT, THE IMPLANT WAS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12846904 ↗