AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652416061), received between Sep 7, 2021 and Oct 29, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 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.

• MalfunctionOct 29, 2025Material Opacification; Material Deformation; Material Opacification; Material Deformation

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED GLISTENINGS AND FEELS LIKE HIS VISION WAS GETTING WORSE. THERE WAS SOME SORT OF HAZINESS OVER THE POSTERIOR ASPECT OF THE LENS. THE PATIENT HAD YAG (YTTRIUM ALUMINUM GARNET) PROCEDURE AND POSSIBLY VITRECTOMY FOR FLOATERS. ADDITIONAL INFORMATION WAS RECEIVED, IN THE SURGEON PROGNOSIS OVERALL OCULAR HEALTH WAS NORMAL. THE GLISTENINGS ON THE POSTERIOR SURFACE OF THE INTRAOCULAR LENS (IOL) SEEM TO BE LIMITING VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment; Vitreous Floaters

  MAUDE report 23413679 ↗
• InjuryMar 5, 2024Material Discolored; Material Discolored

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS, PIGMENT ON LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS PATIENT HARM. THE DIAGNOSIS OF THE HARM WAS CORNEAL EDEMA SECONDARY TO LENS EXCHANGE. IN THE SURGEON'S OPINION, THE PROGNOSIS IS SUSPECTED VISUAL IMPROVEMENT ONCE CORNEAL EDEMA SUBSIDES.

  Patient problems: Visual Impairment

  MAUDE report 18836136 ↗
• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 12434408 ↗