AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652415453), received between Mar 9, 2021 and May 10, 2022 — classified as 2 injuries, 1 malfunction.

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

• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL MYOPIA, ANISEIKONIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14350455 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACCOUNT MANAGER REPORTED ON BEHALF OF A FACILITY REPRESENTATIVE THAT, FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FEW MONTHS LATER THE PATIENT¿S VISION WAS DECLINED. DOCTOR DID YAG BUT VISION DID NOT IMPROVE. PATIENT WAS UNHAPPY WITH THE VISION. ADDITIONAL INFORMATION WAS RECEIVED FROM A PHYSICIAN THAT, FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED DISTORTED/DECREASED VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE AFTER 2 YEARS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS SENSORY RETINAL DYSTROPHY AND ON DISEASE WHICH CAUSED THE BCVA TO WORSE. THERE IS NO PATIENT HARM INVOLVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13884135 ↗
• MalfunctionMar 9, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS WAS IMPLANTED AND DOCTOR SAW THAT THE LENS HAD A SMALL SMUDGE. THE LENS WAS THEN REMOVED DURING THE INITIAL PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449451 ↗