AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652429771), received between Nov 22, 2022 and Sep 12, 2023 — classified as 4 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. 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.

• InjurySep 12, 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, THE PATIENT EXPERIENCED HALOS AND BLUR, CLINICAL REASON BEING DECREASED BEST CORRECTED VISUAL ACUITY AND GLARE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS EXCHANGED FOR A NON COMPANY LENS. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17728567 ↗
• MalfunctionJul 17, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS SCRATCHED. THE IOL WAS EXCHANGED WITH ANOTHER LENS (SAME MODEL/DIOPTER) DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE PLUNGER WAS PUSHED ONTO THE OPTIC CREATING MULTIPLE SCRATCHES ON THE OPTIC.

  Patient problems: Insufficient Information

  MAUDE report 17335350 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, THE PATIENT WHO HAD AN INTRAOCULAR LENS (IOL) IMPLANT CLAIMED THAT THE GLARE AND HALOS HAD GOTTEN WORSE FOLLOWING THE OPERATION. THE IOL WAS REMOVED AND REPLACED WITH A NON COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WERE DYSPHOTOPSIA AND MONOCULAR DIPLOPIA, WHICH WERE NOT RESOLVED WITH GLASSES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17277185 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL COORDINATOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED UNEXPECTED VISUAL OUTCOME. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 16361361 ↗
• InjuryNov 22, 2022Adverse 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 HALOS AND BLUR VISION. THE PATIENT WAS UNHAPPY WITH THE LENS HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15842689 ↗