AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652389921), received between Dec 19, 2022 and Mar 4, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT FEELS THAT SHE IS SEEING WORSE THAN BEFORE SURGERY, AT ALL DISTANCES. THE PATIENT ALSO EXPERIENCED SIGNIFICANT GLARE FROM TRAFFIC AT NIGHT, IN THE FORM OF HALO EFFECTS (THREE RINGS AROUND EACH LAMP). THE PATIENT ALSO DEVELOPED POSTERIOR CAPSULE OPACIFICATION WHICH WAS TREATED USING YAG CAPSULOTOMY. THE SURGEON STATED THAT THE PATIENT'S MAIN ISSUE WAS DRY EYE WHICH WAS TREATED USING THE LUBRICATING EYE DROPS. THE PATIENT ALSO HAD VITREOUS DETACHMENT AROUND THE MACULA. THE PATIENT WAS ALSO TREATED WITH NON STEROIDAL ANTI-INFLAMMATORY DRUG. THE SYMPTOMS WERE STILL CONTINUING. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, THE LENS REMAINS IMPLANTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Posterior Capsule Opacification; Visual Disturbances; Vitreous Detachment

  MAUDE report 21512841 ↗
• MalfunctionJan 2, 2024Crack; Device Dislodged or Dislocated; Crack; Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS GOT STUCK IN THE WOUND AND THE LENS WAS PULLED OUT. ON INSPECTING THE LENS, IT WAS FOUND THAT THERE WAS A CRACK CENTRAL IN THE LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424963 ↗
• InjuryMar 9, 2023Adverse 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 BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH A OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT UNHAPPY WITH VISION. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 16511702 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT SYMPTOMS WERE RESOLVED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 16292910 ↗
• InjuryDec 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REASON FOR THE EXPLANT WAS POWER OFF BY 1.50 DIOPTERS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PATIENT HAD EXTREME HIGH VITREOUS MASSIVE E. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 16003958 ↗