AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652419253), received between Jun 16, 2021 and Feb 9, 2023 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 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 HAD EXPERIENCED INTOLERABLE HALOS AND COULD NOT LIVE THE REST OF LIFE WITH THIS, HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.

  Patient problems: Halo

  MAUDE report 16335093 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, PATIENT STATED THERE WAS NO CHANGE IN VISION POST SURGERY AND EXPERIENCED BLURRY VISION AND HAS DIFFICULTY READING. THE LENS WAS EXCHANGED APPROXIMATELY 1 MONTH LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15002912 ↗
• InjuryMar 3, 2022Adverse 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 DISTANCE AND NEAR VISION OF BLURRY VISUAL ACUITY. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. CLINICAL REASON OF EXPLANT MENTIONED WAS STATUS POST RADIAL KERATOTOMY (RK) WAS REFRACTIVE ERROR AND PATIENT UNABLE TO ADAPT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13660908 ↗
• InjuryFeb 17, 2022Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS VERY UNHAPPY AND KEPT STATED LENS WAS DEFECTIVE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT MENTIONED WAS ANISOMETROPIA.

  Patient problems: Visual Impairment

  MAUDE report 13548533 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARES, HALOS, BLURRY VISION AND DYSPHOTOPSIA. THE LENS WAS EXCHANGED APPROXIMATELY 2 MONTHS LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13168146 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CONSUMER EXPERIENCED DISTANT SHADOWS AND DRY EYE. THE PATIENT USED EYE DROPS AND PUNCTAL PLUGS BUT DOESN'T HELP THAT MUCH. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 2 MEDICAL RECORDS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 13079425 ↗
• MalfunctionJul 21, 2021Difficult to Fold, Unfold or Collapse; Difficult to Insert; Failure to Advance; Difficult to Fold, Unfold or Collapse; Difficult to Insert; Failure to Advance

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A LOADING ERROR, FOLDING ISSUE AND THE LENS WAS STUCK IN THE CARTRIDGE. THERE WAS A PATIENT CONTACT WITH THE TIP OF THE CARTRIDGE. THE LENS WAS NOT INSERTED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12201936 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), THE PATIENT WAS UNABLE TO ADOPT TO THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH NON COMPANY IOL.

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

  MAUDE report 12007689 ↗