AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652415682), received between Aug 11, 2022 and Aug 11, 2022 — 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 16, 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.

• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE DRY EYE AND HALOS. USING PILOCARPINE DROPS 1.25% FOR HALOS. LIMITED SUCCESS. TRIED SEVERAL PRESCRIBED PRODUCTS FOR DRY EYE WITH NO SUCCESS. MY READING PRESCRIPTION ONLY IMPROVED BY +.25. DISTANCE DID IMPROVE BY +3.75. STILL NEED GLASSES. SURGEON SAID THERE WAS NOTHING MORE HE COULD DO. HERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT START EXPERIENCING SYMPTOMS SHORTLY AFTER IMPLANT. SHE STILL NEEDS GLASSES AND GENERAL DISCOMFORT IN BOTH EYES. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT USED TEARS AND GEL AT NIGHT AND THERE WAS NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 15208574 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE DRY EYE AND HALOS. USING PILOCARPINE DROPS 1.25% FOR HALOS. LIMITED SUCCESS. TRIED SEVERAL PRESCRIBED PRODUCTS FOR DRY EYE WITH NO SUCCESS. MY READING PRESCRIPTION ONLY IMPROVED BY +.25. DISTANCE DID IMPROVE BY +3.75. STILL NEED GLASSES. SURGEON SAID THERE WAS NOTHING MORE HE COULD DO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT START EXPERIENCING SYMPTOMS SHORTLY AFTER IMPLANT. SHE STILL NEEDS GLASSES AND GENERAL DISCOMFORT IN BOTH EYES. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT USED TEARS AND GEL AT NIGHT AND THERE WAS NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 15208539 ↗