AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652357654), received between May 12, 2021 and Feb 21, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EVEN AFTER THE PERIOD OF 6 MONTHS NOT ABLE TO FULLY SEE AT CLOSE AND MIDDLE RANGE. THIS IMPAIRS IN PERSONAL AND WORK LIFE. AFTER MEETING OPHTHALMOLOGIST, HE TOLD IT WAS THE FAULT OF THE LENSES AND SOME PEOPLE MIGHT NOT REGAIN PROPER VISION AFTER THE OPERATION. BUT IT HAS BEEN ALMOST A YEAR AND STILL COULD NOT SEE PROPERLY AT CERTAIN DISTANCES, HOPE THAT THE DOCTOR WAS MISTAKEN AND IT WAS NOT CAUSED BY THE LENSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS 2 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 21432808 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EVEN AFTER THE PERIOD OF 6 MONTHS NOT ABLE TO FULLY SEE AT CLOSE AND MIDDLE RANGE. THIS IMPAIRS IN PERSONAL AND WORK LIFE. AFTER MEETING OPHTHALMOLOGIST, HE TOLD IT WAS THE FAULT OF THE LENSES AND SOME PEOPLE MIGHT NOT REGAIN PROPER VISION AFTER THE OPERATION. BUT IT HAS BEEN ALMOST A YEAR AND STILL COULD NOT SEE PROPERLY AT CERTAIN DISTANCES, HOPE THAT THE DOCTOR WAS MISTAKEN AND IT WAS NOT CAUSED BY THE LENSES. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS 1 OF 2.

  Patient problems: Blurred Vision

  MAUDE report 21419349 ↗
• InjuryJan 20, 2025Defective Device; Material Twisted/Bent; Defective Device; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGE TO THE HAPTIC ELEMENT AND OPTIC PART BY COMPARING THE INJECTOR PLUNGER. THE IMPLANTATION PROCESS WAS GOING IN ORDINARY MODE. IMPLANTATION WAS CARRIED OUT BY AN INJECTOR OF THE MONARCH, THERE WAS USING SPECIAL VISCOELASTIC SOLUTION. DURING THE ADVANCEMENT OF THE PLUNGER ON THE CARTRIDGE, A PRONOUNCED SENSE OF RESISTANCE WAS NOTED TO THE TIP OF THE INJECTOR, SO THE IMPLANTATION PROCESS IN THE EYE WAS STOPPED, IT WAS DECIDED TO ADVANCE THE LENS. AFTER THE EMISSION OF THE LENS FROM THE CARTRIDGE, THE ABOVE DAMAGE WAS NOTED. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. THE SURGERY WAS COMPLETED WITH APHAKIA, AN IOL OF THE SAME TYPE AND DIOPTER WAS REORDERED AND IMPLANTED IN A DELAYED PERIOD EVERY OTHER DAY. THE PATIENT HAD A DELAYED IMPLANTATION. RESULT OF THE SURGERY WAS SATISFACTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191701 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT HE WAS IMPLANTED WITH INTRAOCULAR LENS (IOL) TWO YEARS AGO. HE HAD VERY BLURRED VISION AND MOREOVER HAD VERY SHARP RINGS AROUND THE LIGHTS AND HALOS. HE HAD TROUBLE IN NIGHT DRIVING AND HAD LITTLE PROBLEM IN READING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18278609 ↗
• MalfunctionMar 9, 2022Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED VIA IOL REPLY CARD THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13712444 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR (IOL) IMPLANT PROCEDURE, THE PATIENT CONTINUOUSLY REPORTED GLARE., THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE APPROXIMATELY 3 MONTHS AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 12376608 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON HAS REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IS VERY UNHAPPY. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT IN HER OPINION, THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT WAS DIAGNOSED WITH CYSTOID MACULAR EDEMA (CME). SHE WAS PRESCRIBED A TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID), AND A TOPICAL STEROID. HER BEST CORRECTED VISUAL ACUITY IS FOUR LINES WORSE THAN BEFORE SURGERY. THE SURGEON BELIEVES THE PATIENT'S VISION WILL IMPROVE WITH RESOLUTION OF THE CME.

  Patient problems: Macular Edema

  MAUDE report 11811742 ↗