AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652416023), received between Aug 16, 2021 and Apr 9, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2024Adverse 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 HAD HARD TIME DRIVING AT NIGHT DUE TO GLARE AND HALOS. THE IOL WAS PLANNED EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL). CLINICAL REASON FOR PLANNED EXPLANT WAS MENTIONED AS DESIGN OF IOL WITH DIFFRACTIVE RINGS CANNOT TOLERATE BY PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT WENT IN FOR THE PLANNED EXPLANT BUT DURING THE OPERATION SURGEON HAD TO ABORT THE PROCEDURE DUE TO COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 19070670 ↗
• InjuryDec 28, 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 HE HAD TROUBLE WITH NIGHT DRIVING DUE TO THE RINGS, GLARE, AND HALOS HE SEES AROUND ALL LIGHT SOURCES. HE NOTICED ISSUE SINCE SURGERY. LAST VISIT TO SURGEON AND WAS TOLD I WOULD SUBSIDE OVER THE NEXT SEVERAL MONTHS. THE PATIENT HAS NOT NOTICED ANY IMPROVEMENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16059171 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED SORE EYES AND BLURRED VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. SHE NOTED THAT THE RIGHT EYE WAS WORSE THAN THE LEFT EYE. IT WAS AS IF LOOKING THROUGH WATER, HAD DIFFICULTY-OPENING EYES AT NIGHT, HALO¿S AROUND HEADLIGHTS, SPIDER WEBS AROUND TRAFFIC LIGHTS AT NIGHT, FLORESCENT LIGHTING WAS A BLUR, WEEPING AND DRY EYES. THE SURGEON INDICATED THAT THE DRY EYES COULD BE THE CAUSE OF THE BLURRED VISION AND SORENESS, WHICH WAS PRESENT PRIOR TO THE IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER INDICATED THAT THE LENSES WERE EXPLANTED FOUR MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE AND THE SYMPTOMS SUBSIDED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Eye Pain; Halo; Visual Impairment

  MAUDE report 12328530 ↗