AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652419130), received between Oct 25, 2021 and Mar 1, 2023 — classified as 3 injuries, 1 malfunction.

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 18, 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.

• InjuryMar 1, 2023Malposition of Device; Malposition of Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT CANNOT SEE DISTANCE OR NEAR CLEARLY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT GIVEN IS TORIC IOL ROTATED OUT OF THE POSITION OF 079 DEGREES INTENDED TO 030 DEGREE.

  Patient problems: Blurred Vision

  MAUDE report 16460481 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION OF THE LENS. THE LENS WAS REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE RESIDUAL REFRACTION HAD CAUSED THE BLURRY VISION.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15726311 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH VISION, PATIENT STATED THAT VISION WAS BLURRY FOR DISTANCE AND NEAR, CANNOT SEE CONTRAST AND THE VISION AT NIGHT WAS VERY BAD WITH GLARE AND HALOS. THE IOL WAS EXPLANTED IN SECONDARY PROCEDURE FOR DIFFERENT COMPANY LENS. THERE WAS NO PATIENT HARM, THE SURGEON PROGNOSIS WAS GOOD, AND PATIENT WAS NOT HOSPITALIZED. NO FURTHER INFORMATION AVAILABLE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 14643743 ↗
• MalfunctionOct 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) REPLACEMENT PROCEDURE, REPLACEMENT LENS FROM THE ORIGINAL PROCEDURE HAS ROTATED. THE PATIENT NOW NEEDS A REFRACTIVE PROCEDURE TO CORRECT THE REFRACTIVE ERROR. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Visual Impairment

  MAUDE report 12688043 ↗