AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652419185), received between Mar 11, 2021 and Aug 14, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS PATIENT NOT ADAPTING TO CURRENT IOL.

  Patient problems: Visual Impairment

  MAUDE report 19979309 ↗
• InjuryAug 13, 2024Adverse 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 VISION IMBALANCE, AND FELT RIGHT EYE WAS STRAINING MORE SINCE SURGERY. CLINICAL REASON FOR EXPLANT WAS REFRACTIVE SURPRISE. THE IOL WAS EXCHANGED FOR DIFFERENT MODEL AND DIOPTER, COMPANY LENS 4 MONTHS 13 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. TARGET WAS NOT ACHIEVED DURING INITIAL SURGERY BUT FOLLOWING IOL EXCHANGE THE PATIENT WAS HAPPY WITH THE VISION AND ISSUES WERE RESOLVED WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Pain; Visual Disturbances; Visual Impairment

  MAUDE report 19973690 ↗
• InjuryDec 11, 2023Adverse 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, PATIENT EXPERIENCED POOR VISION, UNABLE TO READ SO FAR AND STARBURST. CLINICAL REASON WAS MENTIONED AS POORLY BEST CORRECTED VISION AND UNABLE TO SEE AT NIGHT DUE TO DISABLING HALOS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND NO PATIENT HARM WAS REPORTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18299778 ↗
• InjuryFeb 7, 2022Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION ISSUES. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON TO EXPLANT THE LENS DUE TO HAPTIC WAS COMPROMISED WHEN FACILITY LOOKED UNDER MICROSCOPE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, AFTER PRIMARY SURGERY, THE PATIENT WAS BROUGHT BACK TO OPERATION ROOM FOR REPOSITION OF LENS AND NOTED LENS HAPTIC WAS NOTED TO BE COMPROMISED AT THAT TIME. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Disturbances

  MAUDE report 13468861 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT HALF A DIOPTER MORE POWER DUE TO PATIENT ENDED UP FARSIGHTED WITH SOME ASTIGMATISM AFTER SURGERY/ POWER CHANGE. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 11960140 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT WAS UNABLE TO PERFORM ACTIVITIES OF DAILY LIVING. THE IOL WAS EXCHANGED FOR A DIFFERENT MANUFACTURER'S LENS APPROXIMATELY 2 MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE PATIENT IS DOING FINE AFTER THE IOL EXCHANGE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 11758043 ↗
• MalfunctionMar 11, 2021Material Frayed; Material Frayed

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A QUALITY ISSUE WAS NOTICED ON THE PERIPHERY OF THE LENS OPTIC. THE ACCOUNT MANAGER REPORTED PROPER LENS LOADING TECHNIQUE BY THE TECHNICIAN. THE LENS REMAINS IMPLANTED AND NO PATIENT HARM HAS BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11466208 ↗