AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652418676), received between Mar 18, 2021 and Oct 30, 2023 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (2 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2023Material Opacification; Appropriate Device Problem Term/Code Not Available; Material Opacification; Appropriate Device Problem Term/Code Not Available

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND TO BE IS CLOUDY, SO SURGEON SUGGESTED TO EXCHANGE THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18031446 ↗
• InjuryApr 6, 2023Defective Device; Device Dislodged or Dislocated; Defective Device; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS SUPERIORLY DISPLACED. TURNS OUT, THE TRAILING HAPTIC WAS DAMAGED. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. PATIENT WAS VERY HAPPY WITH THE NEW LENS.

  Patient problems: Blurred Vision

  MAUDE report 16691783 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS, RINGS AND STEAKS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT ABLE TO FUNCTION AT NIGHT SECONDARY TO DYSPHOTOPSIA, WHICH DID NOT RESOLVE WITH MEDICAL MANAGEMENT. HENCE, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THERE WAS NO HARM TO THE PATIENT. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16325333 ↗
• InjuryDec 9, 2022Break; Malposition of Device; Break; Malposition of Device

  A PRACTICE MANAGER REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS BROKEN AT HAPTIC OPTIC JUNCTION. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL AND DIOPTER WITHIN 2 WEEKS AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Insufficient Information

  MAUDE report 15948789 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED OVERCORRECTION AND LENS WAS EXPLANTED IN A SECONDARY PROCEDURE FOR A CLINICAL REASON OF MYOPIA. THE LENS WAS REPLACED WITH ANOTHER MODEL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15758201 ↗
• MalfunctionDec 27, 2021Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13087865 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND SURGEON STATED THAT, PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE PATIENT DID NOT TOLERATE THE IOL.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12123097 ↗
• InjuryJun 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT VISION WAS TERRIBLE, NEAR SIGHTED VISION WAS NOT CLEAR AND FARSIGHTED VISION WAS ALMOST NONEXISTENT, PATIENT CANNOT SEE COMPUTER WITHOUT MAGNIFYING LENS AND READERS. ALSO STATED THAT VISION WAS BETTER BEFORE THE CATARACT SURGERY.

  Patient problems: Visual Disturbances

  MAUDE report 11984517 ↗
• InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION AFTER FIVE DAYS THE LENS WAS EXPLANTED DUE TO CAPSULE RUPTURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 11956686 ↗
• InjuryMar 18, 2021Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS THAT WAS EXPLANTED AND REPLACED TWO DAYS FOLLOWING THE INITIAL PROCEDURE DUE TO DECENTRATION OF IOL. THE PATIENT ALSO COMPLAINED OF BLURRY VISION, GLARE AND HALOS. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 11517313 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SAMPLE INTRAOCULAR LENS (IOL) WAS RECEIVED WITH A QUESTIONAIRE REPORTING AN EXPLANT DUE TO A REFRACTIVE ERROR. ADDITIONAL INFORMATION RECEIVED, THE LENS EXCHANGE ON THE RIGHT EYE WAS PERFORMED APPROXIMATELY THREE MONTHS FOLLOWING THE INITIAL PROCEDURE. A DIFFERENT MANUFACTURER LENS WAS USED IN THE EXCHANGE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11516985 ↗