AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652414951), received between Apr 9, 2021 and Sep 20, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. 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 6 most recent of 6 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. 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 OPINION (CATARACT DR.) ADVISED SINCE YAG LASER DONE, WO

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

  MAUDE report 15454883 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CERTIFIED OPHTHALMIC ASSISTANT REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION LOSS WHICH WAS ONGOING, POOR VISION ACROSS ROOM, CLOUDINESS, BLURRY VISION AND WHITE OUT ON ALL DIGITAL SCREENS, GLARE WHICH WAS DAY AND NIGHT AND HEADACHES. DUE TO THE REPORTED SYMPTOMS, THE LENS WAS EXPLANTED APPROXIMATELY A YEAR AFTER IOL IMPLANTATION. THE PHYSICIAN STATES THAT THE PATIENT WAS INTOLERANT TO THE SUSPECT PRODUCT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Headache; Visual Disturbances; Visual Impairment

  MAUDE report 14685840 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND RECEIVED. STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AND THE PROGNOSIS WAS GOOD.

  Patient problems: Visual Disturbances

  MAUDE report 12859671 ↗
• InjuryJul 22, 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 THE PATIENT EXPERIENCED SEVERE GLARE, STARBURST, HALO AT NIGHT TIME AND DRIVING AT NIGHT BORDERS ON BEING DANGEROUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12209995 ↗
• MalfunctionJul 2, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED VIA IOL REPLY CARD THAT THE IOL WAS "OPENED, WASTED, SCRATCHED LENS, NOT IMPLANTED". ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105324 ↗
• InjuryApr 9, 2021Material Opacification; Device Contamination with Chemical or Other Material; Material Opacification; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION RECEIVED FROM PATIENT STATING THAT HER VISION WAS IMPAIRED, SHE HAD UNEXPECTED POST-OP VISUAL PROBLEMS AND PAIN AND THAT THE DISPARITIES WITH HER VISION GAVE HER HEADACHES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Headache; Pain

  MAUDE report 11641911 ↗