AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652419277), received between May 5, 2021 and Mar 19, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HAZY VISION AND POOR NEAR VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 01 MONTH 22 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS SUBJECTIVE VISUAL DISTURBANCE. ADDITIONAL INFORMATION WAS RECEIVED, AFTER REFRACTIVE LENS EXCHANGE PATIENT HAD YTTRIUM ALUMINUM GARNET (YAG) AFTER 12 WEEKS AND LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) AFTER 16 WEEKS FOLLOWING THE INITIAL IMPLANT. PATIENT COULD NOT ADAPT TO LENS AND ALSO HAD SUBJECTIVE VISUAL DISTORTION. PATIENT ISSUES WERE RESOLVED AND THERE WAS NO PATIENT HARM. IN SURGEON PROGNOSIS VISUAL ACUITY WAS IMPROVING AND PATIENT WAITING FOR LIGHT ADJUSTMENTS TO THE NEWLY EXCHANGED LENS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21643790 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR VISUAL ACUITY OF 20/40. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATIONS.

  Patient problems: Blurred Vision

  MAUDE report 15698578 ↗
• InjuryAug 5, 2022Adverse 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 CLOUDY VISION, POOR DISTANCE VISION AND GLARE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15176674 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HALOS, GLARE AND WAVY VISION. PATIENT INTOLERANT OF SIDE EFFECTS OF LENS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14733738 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED HALOS AND UNUSUAL DISCOMFORT. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Discomfort; Halo

  MAUDE report 12736888 ↗
• InjurySep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DISLOCATED DUE TO CAPSULAR INSTABILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12423723 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED "EXCESSIVE HALOS AND GLARE". THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL APPROXIMATELY 3 MONTHS FOLLOWING THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11780759 ↗