AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60 (REF TFAT60.160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652420211), received between Mar 8, 2021 and Jul 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Material Twisted/Bent; Material Twisted/Bent

  THE REPORT WAS RECEIVED FROM A GOVERNMENT AGENCY SHARING A MEDWATCH FORM, TO REPORT A PROBLEM RECEIVED FROM A PATIENT THAT, DOCTOR PERFORMED CATARACT SURGERY WITH COMPANY MULTI FOCAL LENS IN BOTH THE EYES. THE LENS IN THE LEFT EYE HAD NEVER WORKED. THE NEW LENS HAD CAUSED DOUBLE VISION AND BLURRED VISION IN THE LEFT EYE. REPORTED THIS TO THE DOCTOR AND HE SAID THAT THE NEW LENS WRINKLED WHEN IT WAS INSERTED. HE PERFORMED ANOTHER SURGERY TO CORRECT THE WRINKLE. THAT DID NOT CORRECT THE PROBLEM. CONSULTED TWO OTHER EYE DOCTORS, AND THEY AGREED THAT THE LENS WAS NOT WORKING BUT DID NOT TELL WHY THE LENS DID NOT WORK. THERE WAS A SPECULATION AS TO WHY THE BLURRED AND DOUBLE VISION. PROBLEM COULD BE THAT THE WRONG LENS WAS USED IN THE LEFT EYE; DOCTOR'S ASSISTANT COULD HAVE HANDED HIM THE WRONG LENS, LENS MIGHT HAVE NOT BEEN CORRECTLY MARKED IN THE PACKAGE BUT BOTTOM LINE THE VISION WAS NOT CORRECT IN THE LEFT EYE. THE DOCTOR THAT HE WAS SEEING PRESCRIBED A CONTACT LENS THAT MUST BE WORN DAILY. THIS WAS A CORRECTION LENS. BUT AS PER THE PATIENT, THE CATARACT SURGERY SHOULD HAVE CORRECTED THE VISION AND SHOULD NOT HAVE TO BUY CONTACT LENS FOREVER TO CORRECT THE VISION THAT SHOULD HAVE BE

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 22608806 ↗
• InjuryNov 8, 2021Malposition of Device; Malposition of Device

  A PATIENT REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS STARTED TO TURN AND AS A RESULT THE VISION WAS CHANGING. THE RING WAS PLACED TO KEEP IT FROM TURNING AND THE VISION IS NOW STABLE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED REPORTING THAT IN THE SURGEONS OPINION THE PRODUCT DID NOT CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 12770821 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN IOL EXCHANGE, THE PATIENT IS HYPEROPIC. A YAG LASER WAS PERFORMED. THIS FILE IS ASSOCIATED WITH MEDICAL DEVICE REPORT NUM 1119421-2021-00408.

  Patient problems: Visual Impairment

  MAUDE report 11436011 ↗