AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652419246), received between May 12, 2021 and Jul 25, 2024 — classified as 8 injuries.

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 18, 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.

• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS INSERTED A YEAR AGO, PATIENT HAD ISSUES WITH FOCUS, BLURRED VISION, DOUBLE VISION AND OTHER PROBLEMS. CONSUMER ALSO STATED LEFT EYE HAS BEEN RELATIVELY PROBLEM FREE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED DRYNESS, UNABLE TO READ AFTER A SHORT TIME MAYBE 30 MINUTES, FEELS INFLAMED AND IRRITATION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATED WHEN PATIENT WAS SITTING TRYING TO READ. IF PATIENT CLOSE LEFT EYE JUST TO SEE HOW THE RIGHT EYE IS FUNCTIONING PATIENT HAD A TOTAL BLUR. CONSUMER CANNOT READ ANYTHING THROUGH THAT EYE.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Dry Eye(s); Eye Irritation; Visual Impairment

  MAUDE report 19825806 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, POST 2 YEARS, THE PATIENT HAD POOR QUALITY OF VISION, COULDN'T SEE THE SMALL PRINT ON THE TV, NOR READ UP CLOSE AND NEEDED A LOT OF LIGHT TO SEE. THE SURGEON DID A LASER PROCEDURE TO HELP AND IT HAS NOT. THE VISION WAS "DRIVING HIM CRAZY". THE SURGEON WAS UNABLE TO UNDERSTAND WHY HE WAS NOT SEEING WELL. SURGEON HAS DONE A LOT OF TESTING IN THE OFFICE AND SAYS HIS VISION WAS FINE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT QUALITY VISION WAS DECREASING. THE YAG LASER WAS DONE BUT STILL THE VISION WAS DETERIORATING. THE SURGEON AND OPTOMETRIST SAID THAT NUMBERS LOOK GOOD AND NO CLINICAL REASON FOUND. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18702229 ↗
• InjuryDec 26, 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 HAD GHOST IMAGES BELOW REAL IMAGE, SEEING DOUBLE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS GHOST IMAGES WITH NEED FOR LENS ROTATION AND RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Diplopia/Double Vision; Visual Impairment

  MAUDE report 18392046 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DIMINISHED VISION AND VISION BLURRY. IT WAS NOTICED THAT ONE OF THE HAPTIC WAS DISLOCATED. THE IOL WAS EXCHANGED FOR OTHER MODEL OF COMPANY LENS 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 17603758 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES THE REPLACEMENT LENS MODEL HAS BEEN PROVIDED. IT WAS REPORTED THAT A 20.5D LENS WAS EXCHANGED FOR A UNKNOWN DIOPTER LENS DUE TO BLURRY VISION. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 13520665 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN IOL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE WHEN DRIVING AT NIGHT. THE LENS WAS REPLACED APPROXIMATELY 7 MONTHS LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12665738 ↗
• InjuryJul 29, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION, UNABLE TO READ SMALL PRINT WITH NO IMPROVEMENT SINCE THE PROCEDURE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXCHANGE WAS "IOL MALFUNCTION". ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12246165 ↗
• InjuryMay 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A FACILITY REPRESENTATIVE REPORTED THAT TWO MONTHS FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED FOR THE REASON PATIENT ADAPTATION ISSUES AND UNREALISTIC EXPECTATIONS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11813783 ↗