AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652419260), received between Mar 30, 2021 and Dec 2, 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.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PHOTOPHOBIA AND HALOS. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 4 MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT THERE WAS NO PATIENT HARM AND PATIENT HAD TWO SURGERIES INSTEAD OF ONE. THE SURGEON PROGNOSIS WAS GOOD.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12915909 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REFRACTION ERROR AND WAS NOT HAPPY. THE LENS WAS EXPLANTED FOR A DIFFERENT LENS WITHIN TWO MONTHS AFTER INITIAL IMPLANTATION. THE CLINICAL REASON OF EXPLANT WAS HYPEROPIC SURPRISE.

  Patient problems: Visual Impairment

  MAUDE report 12487466 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DISSATISFIED WITH THE RESULT DUE TO NIGHT DRIVING ISSUES AS HE IS A TOW TRUCK DRIVER. HE REPORTED POOR DISTANCE VISION AND DEBILITATING NIGHT HALOS. THE IOL WAS REPLACED WITH A DIFFERENT MODEL IOL. ADDITIONAL INFORMATION PROVIDED BY THE SURGEON THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MANUFACTURER'S IOL. THERE WAS NO PERMANENT HARM TO THE PATIENT. THE PATIENT'S ISSUES HAVE RESOLVED AND THE PROGNOSIS IS EXCELLENT.

  Patient problems: Halo; Visual Impairment

  MAUDE report 11588384 ↗