AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652414999), received between Mar 18, 2021 and Jun 2, 2022 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, PATIENT EXPERIENCED CLOUDY VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14583918 ↗
• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE HALOS, STAR BUSTS, LIGHT SENSITIVITY, LOSS OF CONTRAST, LOSS OF DEPTH PERCEPTION, ALL RANGES OF VISION WAS POOR AND SHE HAD FLOATERS ALONG WITH FUZZY CLOUDS IN HER VISON AFTER SURGERY. THERE ARE 3 AREAS OF IRIS ATROPHY AT 3, 6, AND 9 WHERE. THE STROMAL FIBERS APPEARED TO BE WHITENED A BIT. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 6 MONTHS AFTER INITIAL IMPLANTATION. IN THE SURGEON¿S OPINION MULTIFOCAL LENS INTOLERANCE CAUSE OR CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

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

  MAUDE report 12826716 ↗
• InjuryOct 26, 2021Malposition of Device; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION ISSUES, COULD NOT READ DOCTORS NOTES AND POOR FIXATION OF IOL. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12697771 ↗
• MalfunctionOct 25, 2021Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED AN INTRAOCULAR LENS WITH A QUALITY ISSUE AND THERE WAS SOMETHING WRONG WITH THE LENS, THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692283 ↗
• InjuryAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) DUE TO POOR VISION. THE IOL WAS REPLACED WITH AN ALTERNATE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 12269128 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRED VISION AND POOR CONTRAST. POST FOUR MOTHS OF IMPLANTATION THE LENS EXPLANTED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11832689 ↗
• InjuryMar 18, 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 FOG AND VISION IS NOT SHARP. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11515347 ↗