AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652415019), received between Mar 3, 2021 and Aug 5, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE CONSUMER HAD BEEN EXAMINED AND THAT NOTHING MORE COULD BE DONE. A LASER PROCEDURE WAS PERFORMED TO CLEAR UP SOME FILM OR FIBERS.

  Patient problems: Blurred Vision; Vitreous Floaters

  MAUDE report 22714109 ↗
• InjuryDec 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HAZY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS SIGNIFICANT SUBLUXATION SECONDARY TO PSEUDO EXFOLIATION. THERE WAS NO PATIENT HARM REPORTED. THE SURGEONS PROGNOSIS WAS DISLOCATED IOL ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16077378 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT HAD HALOS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo

  MAUDE report 14692442 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, HALOS AT NIGHT AND VISION WAS NOT SHARP. THE IOL WAS EXPLANTED 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 14594585 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE THE PATIENT WAS HAVING FOGGY VISION, DIFFICULTY DRIVING AT NIGHT - CIRCLES AROUND LIGHTS. ADDITIONAL INFORMATION WAS PROVIDED BY CONSUMER THAT, THE PATIENT WAS EXPERIENCING STARBURST AND MULTIPLE HALOS ALL AROUND AND OF ALL COLORS. DURING CHRISTMAS TIME THE 10 FT CHRISTMAS TREE WAS BEAUTIFUL BUT WAS OVERWHELMING FOR THE PATIENT TO LOOK AT. DURING THAT TIME EYE STARTED TO TEAR. DAILY THROUGHOUT THE DAY THE PATIENT WAS HAVING DISRUPTIVE TEARING. THE PATIENT WAS GIVEN ANTIBIOTIC OINTMENT FOR NIGHTTIME WHICH HAS NOT PROVIDED ANY RELIEF. AT NIGHTTIME THE PATIENT DO NOT DRIVE BECAUSE EACH LIGHT (THE STREET LIGHTS, THE STOP LIGHTS, THE NIGHT LITE ON ONCOMING LIGHTS AND THE TAILLIGHTS OF CARS) RESEMBLANCE OF A PLANETARY SOLAR SYSTEM THAT HAD MULTIPLE CIRCLES AROUND THEM.

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

  MAUDE report 13977772 ↗
• MalfunctionFeb 8, 2022Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SCRATCH OR SERRATION WAS APPEARED ON THE ANTERIOR SIDE OF THE LENS. IT WAS NOT KNOWN IF THE LENS HAD THIS DEFECT PRIOR TO MANUAL LOADING OR IF IT OCCURRED AS A RESULT OF THE SCRUB TECH LOADING THE LENS WITH LOADING FORCEPS. THE PHYSICIAN DECIDED NOT TO EXPLANT THIS LENS AS IT WILL NOT DEGRADE THE PATIENT VISUAL PERFORMANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478325 ↗
• InjuryDec 15, 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, PATIENT HAS RESIDUAL CYLINDER BOTH EYES WITH OPTIWAVE REFRACTIVE ANALYSIS. SURGEON IS UNHAPPY WITH OUTCOME. THE IOL EXCHANGE HAS BEEN PLANNED ON (B)(6) 2021. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND PROVIDED THAT THE IOL WAS REPLACED WITH ANOTHER LENS FOLLOWING THE INITIAL PROCEDURE. 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; Visual Impairment

  MAUDE report 13010172 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT WAS UNABLE TO SEE CLEAR AND WAS HAVING NEGATIVE DYSPHOTOPSIA. ADDITIONAL INFORMATION RECEIVED FROM DOCTOR THAT, AN IOL REPOSITIONING WAS PERFORMED TO THE PATIENT INSTEAD OF AN IOL EXCHANGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12689846 ↗
• InjuryJul 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IS UNABLE TO SEE AT DISTANCE AND INTERMEDIATE. IT WAS ALSO REPORTED THAT THERE WAS A LENS MALFUNCTION. POST IMPLANTATION OF APPROXIMATELY EIGHTEEN MONTHS, THE IOL WAS EXCHANGED WITH A MONOFOCAL LENS AS A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12127553 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED INTOLERABLE HALOS AT NIGHT AND DYSPHOTOPSIA. POST IMPLANTATION OF APPROXIMATELY FOURTEEN DAYS THE LENS WAS EXCHANGED FOR A MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11959726 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER THE INITIAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A PATIENT COMPLAINED OF "NO IMPROVEMENT IN VISION, DISTANCE AND NEAR" AND A CLINICAL REASON OF "NO IMPROVEMENT IN VISION, DISTANCE AND NEAR". THIS REQUIRED THE REMOVAL OF THE IOL IN A SECONDARY SURGERY, AND THE IOL WAS REPLACED WITH A SN60WF 22.0D. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAD BEEN REQUESTED AND NEW INFORMATION WAS RECEIVED THAT THE IOL REMOVAL WAS ALSO DUE TO FAILURE TO ADAPT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Unspecified Eye / Vision Problem

  MAUDE report 11618976 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS BOTHERED BY "SEVERE GLARE." THE IOL WAS EXCHANGED A MONTH AFTER INITIAL IMPLANTATION FOR ANOTHER LENS DUE TO A REFRACTIVE ERROR. THE SURGEON HAS REPORTED THE PATIENTS ISSUES HAVE RESOLVED WITH THE EXCHANGED LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 11426291 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) APPROXIMATELY 1 MONTH FOLLOWING THE INITIAL LEFT EYE IMPLANTATION PROCEDURE. THE PATIENT REPORTED POOR VISION AT ALL DISTANCES. THE HEALTHCARE PROFESSIONAL INDICATED THAT THE PATIENT SAW POORLY AFTER CORRECTING THE RESIDUAL REFRACTIVE ERROR POSSIBLY DUE TO A SMALL PUPIL. THE PATIENT IS HAPPY WITH THE REPLACEMENT IOL.

  Patient problems: Blurred Vision

  MAUDE report 11407060 ↗