AcrySof™ IQ PanOptix™ Toric UV IOL TFAT30 (REF TFAT30.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652418751), received between Apr 28, 2021 and Feb 5, 2024 — classified as 10 injuries, 2 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18639525 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT TOLERATE GLARE/HALOS. THE IOL HAS BEEN REPLACED WITH ANOTHER IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17459323 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND DYSPHOTOPSIA. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15257218 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BUYER REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, PATIENT HAD BLURRINESS. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS "DISSATISFIED WITH OUTCOME, BLURRINESS." ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15071911 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AT DISTANCE AND NEAR. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. THE PATIENT WAS UNHAPPY WITH RESULTS AT POST-OP. THE SURGEON DOES NOT BELIEVE THE ISSUE WAS DUE TO LENS. NO FURTHER INFORMATION IS EXPECTED

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14187782 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13938271 ↗
• InjuryMar 11, 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 DYSPHOTOPSIA. THE LENS WAS EXPLANTED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. AS PER THE SURGEONS OPINION PRODUCT DID NOT CONTRIBUTED FOR THE EVENT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13731948 ↗
• InjuryNov 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL DID NOT CAUSE OR CONTRIBUTE TO THE EVENTS OF BLURRY VISION. THE BLURRY VISION AND EXPLANT WERE DUE TO A REFRACTIVE ERROR. THE INITIAL IOL WAS REPLACED WITH THE SAME MODEL IOL, BUT 1.5 DIOPTER DIFFERENCE IN POWER. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12868139 ↗
• InjuryNov 9, 2021Adverse 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 GLARE, GHOSTING, RINGS IN VISION AND DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 12779034 ↗
• MalfunctionAug 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD POOR AND CLOUDY VISION. CLINICAL REASON FOR EXPLANT "IOL MALFUNCTION, DEFECTING IOL". ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 12330543 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED BLURRY VISION, HIGH ANGLE ALPHA AND WAS NOT SATISFIED WITH THE VISION. THE LENS WAS EXCHANGED WITH A DIFFERENT LENS DURING SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING IN THE SURGEON¿S OPINION THE PRODUCT CAUSED THE EVENT.

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

  MAUDE report 11789505 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT APPROXIMATELY 6 WEEKS AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, IT WAS EXCHANGED FOR ANOTHER LENS OF SAME DIOPTER, BUT DIFFERENT MODEL. THE LENS WAS EXCHANGED BECAUSE THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 11739023 ↗