AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652415958), received between Sep 13, 2021 and Oct 20, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT COMPLAINED ABOUT LOSS OF VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR CLINICAL REASON OF PROGRESSIVE LOSS OF VISION WHICH INTERFERING WITH DAILY ACTIVITIES. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12666144 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACCOUNT MANAGER REPORTED ON BEHALF OF SURGEON THAT, FOLLOWING INTRAOCULAR (IOL) LENS IMPLANTATION, THE PATIENT FELT UNCOMFORTABLE, THE ANTIBIOTIC MEDICATION ALSO BURNED REALLY BAD WHEN SHE PUTS IN. THREE WEEKS POST IOL IMPLANTATION, THE PATIENT WAS SEEING PRETTY WELL, HOWEVER, WAS STILL HAVING HALOS, PERIPHERAL HAZE AND HEADACHES TOO. PATIENT WAS USING A CORTICOSTEROID EYE DROP. THE PATIENT ALSO EXPERIENCED STINGING AND ACHING IN THE LEFT EYE THAT COMES AND GOES SINCE SURGERY AND ALSO HAD A BLACK EYE UNDER HER EYE. SIX WEEKS POST OPERATION, EYE STILL HURTS AND IT FELT LIKE A MIGRAINE IN HER EYE WITH FOREIGN BODY SENSATION, VERY PHOTOPHOBIC, STILL HAD HALOS THAT WERE NOT IMPROVING AT ALL. NINE WEEKS POST-OP, HER VISION WAS DOING FINE EXCEPT HALOS AND GLARE. THE PATIENT WAS CONTINUING WITH ANTIBIOTICS, ANTI-INFLAMMATORY DRUG AND CORTICOSTEROIDS. SIX MONTHS POST-OP THE CONTEXT WAS REPORTED AS DRIVING, WATCHING TV, WHILE READING; SEVERITY IS DESCRIBED AS MODERATE. PATIENT DESCRIBED THE FOLLOWING SIGNS AND SYMPTOMS: STILL HAS GLARE, HER DISTANCE VISION IS NOT GREAT SOME DAYS AND CANNOT SEE TO READ WELL IN REAL LIFE SITUATIONS LIKE READING A COOKBOOK. NO MEDICATIONS WERE REPORTED THAT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Discomfort; Eye Pain; Foreign Body Sensation in Eye; Halo; Headache; Visual Disturbances; Visual Impairment

  MAUDE report 12462343 ↗