AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652429689), received between Feb 17, 2023 and Mar 7, 2025 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2025Adverse 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, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT COULD NOT ADAPT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED NON COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21549251 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PATIENT COMPLAINED OF WRONG VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17540186 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED AN EXPLANTED INTRAOCULAR LENS WITH REASON CANNOT SEE DISTANCE OR TO READ WELL, CLINICAL REASON BEING POOR PATIENT ADJUSTMENT, FOLLOWING AN INITIAL IMPLANT PROCEDURE. THE IOL WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17048403 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A CLOUD OVER HIS VISION AND WAS UNABLE TO DRIVE DUE TO HIS VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE.  ADDITIONAL INFORMATION WAS RECEIVED STATING NO PATIENT HARM TO PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16393825 ↗