AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652357708), received between May 7, 2022 and May 28, 2024 — classified as 5 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, EXPERIENCED VISUAL IMPAIRMENT ,BLURRY VISION BOTH DISTANCE AND NEAR. THE PATIENT HAD INTERVENTION. THE SYMPTOMS WERE CONTINUING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19403350 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POOR VISION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 17757103 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT SUFFERED CHAINING (WHICH FELT LIKE A SENSATION OF A CONTACT LENS COMING OUT OF THE EYE), BLURRY/FOGGY VISION DISRUPTING ALL ACTIVITIES (NEAR/FAR/IN-BETWEEN). IT APPEARED AS THOUGH THE LENS WAS GROWING INSIDE THE EYE. THE PATIENT'S VISION WAS GREAT UP CLOSE AND HAD GOTTEN WORSE FOLLOWING THE IMPLANT. THE PATIENT HAD NO TROUBLE SEWING OR CROCHETING BEFORE THE IMPLANTATION, BUT AFTERWARD, NEEDED GLASSES TO CARRY ON WITH EVERYDAY ACTIVITIES. THE INTERMEDIATE. DISTANCE AND FAR VISION WAS NOT SHARP. THE IMPLANTED LENS DID NOT CORRECT THE DULL APPEARANCE. PATIENT WAS NOT SATISFIED WITH THE RESULTS. THE DOCTOR CONCLUDED FROM THE MEDICAL PROGNOSIS THAT THE LENS WAS IN PLACE AND ADVISED WAITING 6-8 MONTHS TO SEE IF SYMPTOMS IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17069650 ↗
• InjuryNov 4, 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 IOL POWER WAS OFF TO SOME DEGREE. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 1 MONTH OF INITIAL IMPLANTATION. THE CLINICAL REASONS FOR THE EXPLANT WERE THAT VISION WAS BLURRY, TROUBLE FOCUSING, AND THE EYE WAS RED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Red Eye(s); Visual Disturbances; Visual Impairment

  MAUDE report 15734695 ↗
• InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED HALOS, NIGHT DRIVING WORSE THAN BEFORE SURGERY AND PATIENT WAS PHOTOSENSITIVE. THE LENS WAS EXCHANGED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 14313865 ↗