AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652429665), received between Apr 18, 2023 and Sep 12, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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.

• InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT PLANNED TO EXPLANT THE LENS DUE TO LENS TOUCHING THE IRIS. SHE STATES AT THE ORIGINAL SURGERY THE CAPSULE BROKE AND THE SURGEON IMPLANTED THE LENS OVER THE CAPSULE. SHE WAS SEEKING INFORMATION ON IF THE LENS CAN BE PRESERVED AND REPOSITIONED. ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS. PATIENT VISION WAS DOING MUCH BETTER ALREADY AND THE EYE FEELS GOOD.

  Patient problems: Capsular Bag Tear

  MAUDE report 20198567 ↗
• InjuryNov 27, 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 IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DYSPHOTOPSIA. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18208599 ↗
• InjuryNov 24, 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 INTOLERANT VISUAL OBSERVATIONS OF GLARE AND CLINICAL REASON FOR EXPLANT BEING SUBJECTIVE VISUAL ABERRATIONS. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 18204601 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT'S EYES WERE FAILING AND PATIENT WAS UNHAPPY WITH THE RESULTS. THE VISION NEVER GOT CORRECTED PERFECTLY AND THE READING VISION WAS DECREASED OVER LAST TWO MONTHS. THE PATIENT UNDERWENT POSTERIOR CHAMBER YTTRIUM-ALUMINUM-GARNET LASER AROUND A YEAR OR SO AGO. PATIENT'S OPTOMETRIST DID NOT SEE ANYTHING THAT WOULD WARRANT VISION CHANGE AND PRESCRIBED TO WEAR GLASSES. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17808950 ↗
• InjuryMay 1, 2023Adverse 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 AURA, GLARE, HALOS AND BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS HIGHER ORDER ABERRATIONS. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS MAY HAVE ALSO CAUSED SEVERAL BLURRED VISION ALONG WITH OPTIC NEUROPATHY. PATIENT'S SYMPTOMS WERE RESOLVED.

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

  MAUDE report 16843719 ↗
• 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 RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16762127 ↗