AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652418904), received between Dec 10, 2021 and Jul 10, 2023 — 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.

• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY DISTANT VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT UNHAPPY WITH VISUAL OUTCOME.

  Patient problems: Blurred Vision

  MAUDE report 17287656 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT EXPERIENCED UNKNOWN ISSUE. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS ONE MONTH AFTER INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS POOR VISUAL RESULTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM AND THE PROGNOSIS WAS GOOD. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: Visual Impairment

  MAUDE report 12978891 ↗