AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652429672), received between Nov 16, 2022 and Jul 11, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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.

• InjuryJul 11, 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 FELT DIFFICULTY READING. THE IOL WAS EXCHANGED FOR ANOTHER LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MILD HYPEROPIA, NEEDS TO INCREASE THE LENS POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17298258 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND BLURRED VISION. THE IOL WAS EXCHANGED IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16762130 ↗
• InjuryDec 7, 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 BLURRED VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15930744 ↗
• InjuryDec 5, 2022Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Power Calculation Error; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISION IN DISTANCE AND NEAR. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 17 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS UNKNOWN REASON AND ATTEMPTED ALL TREATMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 15914451 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION DISTANCE AND NEAR. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS UNABLE TO CORRECT VISION. ADDITIONAL INFORMATION WAS RECEIVED STATING IN THE SURGEON'S OPINION, THE PRODUCT CONTRIBUTED TO THE EVENT. THEY WERE TRYING TO DETERMINE IF THERE WAS ANY PROBLEM WITH THE LENS IMPLANT. THEY TRIED EVERYTHING TO OPTIMIZE REFRACTION/OCULAR SURFACE/OTHER REASONS FOR POOR VISION INCLUDING SECOND OPINION AND AGGRESSIVE OCULAR SURFACE TREATMENTS. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENT.

  Patient problems: Blurred Vision

  MAUDE report 15804351 ↗