AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652418621), received between May 7, 2021 and Jul 14, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE, UNSPECIFIED REASONS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT EXPERIENCED ANISOMETROPIA, IRRITATION, COLOR VIVID, BLURRED VISION, INTRAOCULAR PRESSURE INCREASED. EVENT OUTCOME WAS IMPROVING.

  Patient problems: Blurred Vision; Intraocular Pressure Increased; Irritability; Visual Impairment

  MAUDE report 15010185 ↗
• 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 LEFT 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 14672888 ↗
• InjuryDec 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY OF VISION, BOTHERED BY GLARE, HALOS AND INTOLERANT OF MULTIFOCAL LENS LIKELY DUE TO INCREASED HIGHER ORDER ABERRATIONS. THE LENS WAS LATER EXCHANGED APPROXIMATELY 1 MONTH LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13083961 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED NO CLEAR ASTIGMATIC AXIS AND THE PATIENT WAS NOT HAPPY. POST IMPLANTATION OF APPROXIMATELY ONE MONTH THE LENS WAS EXPLANTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Eye / Vision Problem

  MAUDE report 12093623 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED, THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL). THE PATIENT WAS UNHAPPY WITH VISION. AND UNEXPECTED OUTCOME. THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED. UPON QA REVIEW, THE FILE WAS IDENTIFIED AS A DUPLICATE FILE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment

  MAUDE report 11981826 ↗
• InjuryMay 7, 2021Adverse 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) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED POOR DISTANCE AND NEAR VISION. POST IMPLANTATION CALCULATIONS SUGGEST THE NEED FOR A STRONGER TORIC. THE IOL WAS EXCHANGED APPROXIMATELY TWO MONTHS FOLLOWING THE INITIAL IOL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11794498 ↗