AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652418607), received between Oct 20, 2021 and Apr 6, 2023 — 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. How this data works · Data updated Oct 13, 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.

• InjuryApr 6, 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 PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE HALOS. THE IOL WAS EXPLANTED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION STATED THAT PATIENT'S RIGHT EYE WAS INVOLVED AND THE PATIENT'S ISSUES HAVE BEEN RESOLVED.

  Patient problems: Halo

  MAUDE report 16689511 ↗
• InjuryJun 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 FACED DIFFICULTIES NOT SURE IF IT IS DUE TO THE LENSES AND MIGHT BE AN ALLERGIC REACTION TO THE LENS MATERIAL. THE PATIENT SYMPTOMS ARE BURNING AND STABBING PAIN, HEADACHES FROM EYE STRAIN, WAVY AND BLURRY VISION, FEELS LIKE SAND IS IN HER EYES, HAS TO WEAR SUNGLASSES BECAUSE OF LIGHT SENSITIVITY, AND THIS HAS ALL AFFECTED HER QUALITY OF LIFE AND AS CAUSED DEPRESSION. PATIENT HAS TRIED DROPS AND OINTMENTS WHICH HAVE CAUSED MORE PAIN AND BELIEVES PATIENT IS ALLERGIC TO THE PRESERVATIVES IN THOSE PRODUCTS. THE DOCTOR SWITCHED HER TO XIIDRA, BUT IT'S NOT HELPING. THE PATIENT HAS BLEPHARITIS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Depression; Dry Eye(s); Eye Pain; Foreign Body Sensation in Eye; Headache; Inflammation; Visual Disturbances

  MAUDE report 14672887 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED APPROXIMATELY 4 MONTHS AFTER IMPLANTATION DUE TO PATIENT HAVING HEADACHES, TROUBLE FOCUSING AND CONTRAST PHOTOPHOBIA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Headache; Visual Disturbances; Visual Impairment

  MAUDE report 13416712 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGICAL TECHNOLOGIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT STRAINS TO SEE AND SEES TRIPLOPIA. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL, IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED STATING THERE WAS NO HARM TO PATIENT AND PATIENT ISSUES WERE RESOLVED.

  Patient problems: Eye Pain; Visual Impairment

  MAUDE report 12666087 ↗