AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652418584), received between Dec 23, 2021 and Jun 9, 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 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.

• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION, PATIENT STATED THAT VISION WAS BLURRY FOR DISTANCE AND NEAR, CANNOT SEE CONTRAST AND THE VISION AT NIGHT WAS VERY BAD WITH GLARE AND HALOS. THE IOL WAS EXPLANTED IN SECONDARY PROCEDURE FOR DIFFERENT COMPANY LENS. THERE WAS NO PATIENT HARM, THE SURGEON PROGNOSIS WAS GOOD, AND PATIENT WAS NOT HOSPITALIZED. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 14642207 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED POOR VISION QUALITY AND MONOCULAR DIPLOPIA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE SIX WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PROVIDED AS "DYSPHOTOPSIA, POOR TOLERANCE IN SETTING OF PRIOR EPITHELIAL BASEMENT MEMBRANE DYSTROPHY (EBMD) S/P." ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM AND PATIENT ISSUES WERE RESOLVED.  SURGEON BLAMES CAUSE ON HIGHER ORDER CORNEAL ABERRATIONS INCOMPATIBLE WITH DIFFRACTIVE MULTIFOCAL IOL.

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

  MAUDE report 13079365 ↗