AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.090)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652419017), received between May 13, 2022 and May 13, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HAZY VISION AT A DISTANCE, EYE DO NOT WORK TOGETHER. YAG LASER WAS PERFORMED BUT VISION HAS NOT IMPROVED. DIFFICULT TO SEE TO DRIVE TO SEE SIGNS, DRIVING AT NIGHT IS VERY DIFFICULT AND THERE ARE SHADOWS. THE NEAR VISION WAS CLEAR AD PATIENT SENT TO RETINA SPECIALIST THERE WERE NO SIGNS OF BLEEDING AND RETINA IS CLEAR. PATIENT IS UNHAPPY WITH LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING EYES ARE NOW BURNING TOO, BOTH EYES FEEL SORE AND INSTRUCTED TO SEE A DOCTOR OR SEE A SECOND OPINION SINCE THIS IS NOT A NORMAL SYMPTOM TO FEEL AND THE LAST TIME SHE HAS SEEN HER DOCTOR WAS 2 WEEKS AGO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Burning Sensation; Eye Pain; Visual Disturbances; Visual Impairment

  MAUDE report 14398613 ↗
• InjuryMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HAZY VISION AT A DISTANCE, EYE DO NOT WORK TOGETHER. YAG LASER WAS PERFORMED BUT VISION HAS NOT IMPROVED. DIFFICULT TO SEE TO DRIVE TO SEE SIGNS, DRIVING AT NIGHT IS VERY DIFFICULT AND THERE ARE SHADOWS. THE NEAR VISION WAS CLEAR AD PATIENT SENT TO RETINA SPECIALIST THERE WERE NO SIGNS OF BLEEDING AND RETINA IS CLEAR. PATIENT IS UNHAPPY WITH LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING EYES ARE NOW BURNING TOO, BOTH EYES FEEL SORE AND INSTRUCTED TO SEE A DOCTOR OR SEE A SECOND OPINION SINCE THIS IS NOT A NORMAL SYMPTOM TO FEEL AND THE LAST TIME SHE HAS SEEN HER DOCTOR WAS 2 WEEKS AGO. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Burning Sensation; Eye Pain; Visual Disturbances; Visual Impairment

  MAUDE report 14398595 ↗