AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652418706), received between Sep 8, 2021 and Oct 28, 2022 — classified as 8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2022Adverse 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 EXPERIENCED PHOTOPSIA, DIFFICULTY DRIVING. THE SURGEON HAD PLANNED FOR EXPLANT. THE REASON FOR EXPLANT MENTIONED AS PATIENT HAVING GLARE WITH VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15693215 ↗
• InjuryOct 19, 2022Adverse 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 EXPERIENCED VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 15631140 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A OPERATING ROOM MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 5 WEEKS OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15536451 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTORTION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THE PHYSICIAN WAS UNABLE TO REFRACT HER TO BETTER THAN 20/40 VISION WITH THE PANOPTIX AND NOW SHE HAS 20/25 UNCORRECTED WITH THE MONO FOCAL LENS AND IS MUCH HAPPIER WITH HER VISION. THE PATIENT PROGNOSIS WAS GOOD. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Visual Disturbances

  MAUDE report 15218997 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISCOMFORT AND POOR VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15191245 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HALOS AND GLARE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15095002 ↗
• InjuryDec 6, 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 WAS UNABLE TO DRIVE AND EXPERIENCED HALOS, GLARE AND BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR A DIFFERENT LENS AFTER INITIAL IMPLANTATION. PATIENT WAS ZERO TOLERANT FOR THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT ISSUES WERE RESOLVED AND THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 12933753 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A MATERIAL MANAGER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POSTERIOR LENS DISLOCATION. THE IOL EXCHANGED FOR ANOTHER LENS (ANOTHER COMPANY MODEL) 64 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12438661 ↗