AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652389969), received between Oct 25, 2021 and Jun 1, 2026 — classified as 5 injuries, 2 malfunctions.

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.

• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER SURGERY THE PATIENT EXPERIENCED THE SYMPTOM THAT APPEARS CLOUDY AFTER SURGERY IT BECAME MORE SEVERE AND THE EXCHANGE WAS CONDUCTED AND THE PATIENT ALSO EXPERIENCING WORSENING BLURRED VISION LEADING TO AN EXCHANGE BEING PERFORMED. THE INTRAOCULAR LENS (IOL) WAS SUBSEQUENTLY REMOVED AND REPLACED WITH UNSPECIFIED REPLACEMENT LENS DURING INITIAL IMPLANTATION PROCEDURE AND PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision

  MAUDE report 25348110 ↗
• InjuryApr 16, 2024Adverse 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 NEGATIVE AND POSITIVE DYSPHOTOPSIA THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 19114677 ↗
• MalfunctionFeb 11, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON LOADED THE LENS INTO PATIENT'S EYE. WHEN INSPECTED UNDER SCOPE NOTICED MARK ON OPTIC AREA. THE SURGEON DID NOT EXPLANT THE LENS INFORMED THAT THE MARK WAS NOT MUCH BUT THERE SHOULD NOT BE ANY. THE PROCEDURE COMPLETED ON THE SAME DAY, NO HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359650 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT WAS UNHAPPY DUE TO BLURRED VISION AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE LENS WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT REPORTED THAT THE VISION WAS NOT CRISP OR SHARP, AND HAD HALOS. THERE WAS NO HARM TO THE PATIENT AND THE SYMPTOMS HAVE RESOLVED. THE PROGNOSIS WAS EXCELLENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16352872 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO SEE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS PROVIDED AS POOR VISUAL ACUITY, UNABLE TO REFRACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14652960 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE VISION BEGAN TO FAIL AND ALSO HAD DRY EYE. THE DOCTOR PERFORMED LAZER TREATMENT ON ONE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 2 MEDICAL RECORDS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE LEFT EYE.

  Patient problems: Corneal Scar; Dry Eye(s); Visual Impairment

  MAUDE report 14265974 ↗
• MalfunctionOct 25, 2021Defective Component; Defective Component

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISION WAS NOT CLEAR. THE PHYSICIAN NOTICED MACULAR PUCKER AND THEN SENT THE PATIENT TO RETINAL SPECIALIST. THE PATIENT WAS CONCERNED BECAUSE THE SPECIALIST HAD A HARD TIME EXAMINING THE EYE AND WORRIED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 12689551 ↗