AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652415422), received between Aug 2, 2021 and Nov 15, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 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 WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 12809577 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD ¿BLURRY VISION WITH SIGNIFICANT GLARE¿. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. PATIENT STATED THAT HIS VISION WAS NEVER CLEAR FROM ONE DAY POST OPERATION. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 12300810 ↗
• InjuryAug 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT POST IMPLANTATION, THE PATIENT EXPERIENCED CONSTANT BLURRED VISION. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 2 WEEKS AFTER INITIAL IMPLANTATION. CONSTANT BLURRED VISION WITHOUT IMPROVEMENT WAS THE CLINICAL REASON GIVEN FOR THE EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12258917 ↗