AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652418652), received between May 25, 2021 and Aug 26, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the patient experienced poor vision and halos. Subsequently the lens was removed and replaced with an unspecified monofocal in a secondary procedure. The clinical reason for explant was intolerable to contrast and halos. Additional information has been requested but is not available at the time of this report. There are two Medical Device Reports associated with this report. This is 2 of 2.

  Patient problems: Visual Disturbances

  MAUDE report 50448578 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND ENHANCEMENT OF ASTIGMATISM DUE TO LASIK BY MULTI FOCAL INTRAOCULAR LENS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15122119 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE IMMEDIATELY AFTER PLACEMENT OF THE LENSES, THE ASTIGMATISM WAS NOT CORRECTED. THE DOCTOR DID YAG LASER WHICH DID NOT HELP. LATER THE TOUCH UP LASIK WAS DONE WHICH CORRECTED THE RESIDUAL ASTIGMATISM BUT THE INTERMITTENT BLURRY AND HAZY VISION CONTINUES. DOCTOR PLACED THE PUNCTUAL PLUGS ON (B)(6) 2021, PATIENT STILL HAVING INTERMITTENT GOOD AND BAD VISION, AND MOSTLY BAD. SOME DAY¿S PATIENT READ NEWSPAPER AND STREET SIGN AND SOME DAYS PATIENT CAN'T. PATIENTS POOR VISION CANNOT BE CORRECTED WITH GLASSES. PATIENT HAS NOT BEEN DIAGNOSED WITH MACULAR EDEMA, BUT IS GOING ON (B)(6) FOR FURTHER TESTING.

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

  MAUDE report 12518028 ↗
• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION WHICH WAS AFFECTING DAILY LIVING ACTIVITIES, ESPECIALLY DRIVING. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE APPROXIMATELY 7 MONTHS AFTER THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12376641 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT POST IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT WAS NOT SATISFIED WITH RESULTS. POST IMPLANTATION AFTER THREE MONTHS THE LENS WAS REPLACED WITH OTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 12325063 ↗
• MalfunctionMay 25, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED VIA IOL REPLY CARD THAT AN INTRAOCULAR LENS (IOL) WAS DAMAGED AND LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878347 ↗