AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419215), received between Apr 26, 2021 and Aug 25, 2022 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXCHANGED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS VISION WAS NOT OPTIMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15291511 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED POOR IMAGE QUALITY AND GLARE. THE PATIENT WAS UNABLE TO ADAPT TO THE LENS OVER TEN MONTHS. THE LENS WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SINCE THE SURGERY, SHE HAS NOT BEEN HAPPY WITH THE QUALITY OF HER VISION. SHE HAD ALSO BEEN BOTHERED WITH GLARE, THE PATIENT DID NOT ADAPT OVER 10 MONTHS. THE LENS WAS LOADED AT THE CENTER CORRECTLY. THERE WAS NO DAMAGE TO THE LENS. THE LENS HAD TO BE REMOVED, IT WAS CUT OUT AND WAS DESTROYED. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND HAD RECOVERED AFTER THE LENS WAS EXCHANGED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13974957 ↗
• MalfunctionJan 13, 2022Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF SCRATCHED INTRAOCULAR LENS. THE PATIENT CONTACT WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13252484 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT ENDED UP SLIGHTLY FARSIGHTED AND THE IOL WAS SITTING SLIGHTLY NASAL. THE IOL WAS EXCHANGED FOR A NON-TORIC IOL OF THE SAME POWER. THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 11726341 ↗