AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652415002), received between Mar 18, 2021 and Sep 20, 2022 — classified as 16 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EPISODES OF RETINAL UVEITIS WITH A GREY CLOUD GOING BACK AND FORTH IN BOTH EYES. THE PATIENT ALSO HAS SENSITIVITY TO FLUORESCENT LIGHTS. THE LENSES HAVE COMPLETELY DISRUPTED PATIENT LIFE. THE PATIENT DID NOT DRIVE AT NIGHT, AND READING WAS DIFFICULT. ADDITIONAL INFORMATION WAS RECEIVED STATING SHORTLY AFTER IMPLANTS, VISION WAS DISTORTED WITH HUGE GRAY FLOATERS IN BOTH EYES, PINK CONJUNCTIVA, WATERY, ITCHY, DIFFICULTY FOCUSING. THE CORTICOSTEROID EYE DROPS STARTED WITH IMPROVEMENT, THEN SYMPTOMS WORSENED, AND INCLUDED HALOS AROUND LIGHTS. THE GREY HAZE CONTINUED AND THE YTTRIUM ALUMINUM GARNET (YAG) LASER PERFORMED WITH LITTLE IMPROVEMENT. THE CHOLINERGIC AGONIST EYE MEDICATION WAS USED FOR 5 WEEKS WITHOUT IMPROVEMENT. OVER SEVERAL MONTHS, PATIENTS HAVE HAD LITTLE RELIEF AND ALSO HAD EYE INFECTIONS, SCLERITIS OF RIGHT EYE. THE LACRIMAL PLUGS PLACED ON EYES WERE TEARING. THE PATIENT SAW RETINAL SPECIALIST, NO INFECTIOUS PROCESS, BUT LARGE AMOUNTS OF DEBRIS IN VITREOUS AND WAS DIAGNOSED WITH UVEITIS. THE PATIENT HAD A 2ND OPHTHALMOLOGY OPI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Confusion/ Disorientation; Conjunctivitis; Eye Infections; Halo; Itching Sensation; Uveitis; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 15454633 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN UNEVENTFUL CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE PATIENT ENDED UP WITH ¿ 0.75 AND HAD MANY COMPLAINTS SUCH AS NEGATIVE DYSPHOTOPSIA, ANISOMETROPIA AND DYSCHROMATOPSIA (SAYING COLORS ARE MUTED). ADDITIONAL INFORMATION WAS PROVIDED THAT THE LENS WAS EXPLANTED AND WAS ABLE TO ARC IN THE INFERIOR FIELD, HAD MUTED IMAGE DISPARITY AND COLOR. NO FURTHER INFORMATION AVAILABLE.

  MAUDE report 13769189 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGERY COORDINATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MULTIPLE HALOS, HEADACHES. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 8 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Headache

  MAUDE report 13450968 ↗
• InjuryDec 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE ONE WEEK FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS "WAXY VISION." ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 13108888 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS SEEING RINGS THAT ARE BOTHERSOME AT NIGHT. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE APPROXIMATELY AFTER 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 13088363 ↗
• InjuryDec 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED IRRITATION AND THE CLINICAL REASON WAS DISLOCATED LENS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A DIFFERENT MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort

  MAUDE report 13026597 ↗
• MalfunctionSep 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH VISION, AND WAS UNABLE TO CORRECT BETTER THAN 20/40. ADDITIONAL INFORMATION WAS PROVIDED THAT THE GLISTENING¿S WAS NOTED ON THE LENS.

  Patient problems: Visual Impairment

  MAUDE report 12513868 ↗
• InjuryAug 19, 2021Defective Device; Difficult to Advance; Defective Device; Difficult to Advance

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THE PATIENT EXPERIENCE EYE PAIN DUE TO HAPTIC BROKE, DOUBLE VISION AND LENS WAS DIFFICULT TO LOAD.

  Patient problems: Eye Pain; Insufficient Information; Visual Disturbances

  MAUDE report 12341108 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INTRAOCULAR LENS WAS EXCHANGED WITH MONOFOCAL LENS IN SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12325618 ↗
• InjuryAug 13, 2021Adverse 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, A PATIENT EXPERIENCED BLURRED VISION, ESPECIALLY AT DISTANCE AND SORE EYES. THE CONSUMER STATED THE BLURRY VISION WAS LIKE LOOKING THROUGH WATER. THE DOCTOR INFORMED THE CONSUMER THE BLURRED VISION WAS CAUSED BY DRY EYES, WHICH WAS DIAGNOSED PRIOR TO SURGERY. THE CONSUMER IS CURRENTLY USING OTC ARTIFICIAL TEARS. IT WAS ALSO REPORTED SHE COULD HARDLY OPEN HER EYES AT NIGHT AND WEEP. WHILE DRIVING AT NIGHT, SHE EXPERIENCED TWO FOOT SPIDER WEBS AROUND TRAFFIC LIGHTS, HALOS AND FLUORESCENT LIGHT IS A BLUR. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE IOL WAS EXCHANGED FOR ANOTHER LENS. THERE ARE TWO REGULATORY REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

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

  MAUDE report 12319786 ↗
• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PERIPHERAL BLURRY, GHOST IMAGING AND CIRCULAR RINGS IN VISION. POST IMPLANTATION OF APPROXIMATELY FOUR MONTHS THE LENS WAS EXCHANGED FOR A ANOTHER LENS.

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

  MAUDE report 12280737 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO INTRACTABLE GLARE AND DECREASED CONTRAST SENSITIVITY. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THE PATIENT FELT THERE WAS A FILM OVER THE VISION AND IT COULD NOT BE LIFTED WITH A REFRACTION OF THE SMALL RESIDUAL REFRACTIVE ERROR AND LACK OF QUALITY OF DISTANCE VISION. IN SURGEON'S OPINION, THE PATIENT FAILED TO NEURO ADAPT AFTER 2 MONTH OF THE SURGERY. THE IOL WAS REPLACED WITH A MONOFOCAL TORIC LENS.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 11892553 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED GLARE AND HALOS. THE LENS WAS EXCHANGED WITH A DIFFERENT LENS IN THE SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11789677 ↗
• InjuryMay 6, 2021Adverse 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 EXPERIENCED GLARE AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER MODEL NINE MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11783612 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT SEE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11656032 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A PATIENT EXPERIENCED " SEVERE GLARE/HALOS/BLUR ESPECIALLY AT NIGHT." THE IOL WAS EXCHANGED FOR A DIFFERENT LENS MODEL APPROXIMATELY 7 MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 11541893 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11515341 ↗