AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652414982), received between Mar 23, 2021 and Jan 10, 2024 — classified as 7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM CONSUMER STATING ISSUE RELATED TO STATINS WHICH SHE WAS USING FOR CHOLESTEROL.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Headache; Visual Disturbances

  MAUDE report 18482425 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A CUSTOMER COMPLAINED OF DRY EYES. THE CUSTOMER HAD TEAR DUCT PLUGS PLACED MULTIPLE TIMES AND UTILIZED THE PRESCRIBED EYE DROPS, BUT THE CONDITION DIDN'T GET ANY BETTER. AFTER APPLYING A PLACENTA PATCH AND AFTERWARDS A LASER TO REDUCE SCAR TISSUE, THE CONSUMER ONCE MORE EMPLOYED THE ADVISED EYE DROPS. EVEN PRESCRIPTION READERS, PRESCRIPTION DISTANCE LENSES, AND TRIFOCAL SPECTACLES WERE UTILIZED BY CONSUMER. ALL OF THESE WERE HELPFUL, BUT THEY DIDN'T SOLVE EVERY ISSUE. FOR EXAMPLE, SOME OF THE LETTERS WERE FADED AND OCCASIONALLY WEREN'T DARK ENOUGH TO BE SEEN ON THE PAGE. NOTHING IN A PICTURE WAS APPARENT TO THE CONSUMER WHEN LOOKED AT IT. LARGE LIGHTED CIRCLES AND LINES AROUND ALL LIGHTS WERE AMONG THE OTHER ISSUES THAT CONSUMER OBSERVED. THIS WAS MOSTLY AN ISSUE WHEN DRIVING THROUGHOUT THE DAY OR MORE SO AT NIGHT BECAUSE IT MADE IT DIFFICULT TO SEE WHEN OTHER CARS WERE AROUND. AS A RESULT, CONSUMER STOPPED DRIVING AT NIGHT. BECAUSE THE CONSUMER HAD DIFFICULTIES WITH DEPTH PERCEPTION, MOVING AROUND WAS PROBLEMATIC, GLARE WAS AN ISSUE, AND SWITCHING FROM LIGHT TO DARK WAS CHALLENGING. TO PERCEIVE AN OBJECT, THE CONSUMER HAS TO LOOK ST

  Patient problems: Dry Eye(s); Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17314276 ↗
• InjuryFeb 9, 2023Adverse 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 EXPERIENCED AN INABILITY TO ADAPT THE LENS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER APPROXIMATELY FIVE MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS SEVERE GLARE AND HALOS. ADDITIONAL INFORMATION WAS RECEIVED STATING NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16337522 ↗
• MalfunctionAug 24, 2022Defective Device; Defective Device

  A FACILITY REPRESENTATIVE REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND DEFECTIVE. ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15285137 ↗
• 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. 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. THE SYMPTOMS WERE RESOLVED TO THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 12826717 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO TOLERATE IOL DUE TO MACULAR DYSTROPHY. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS DIAGNOSED WITH MACULAR TELANGIECTASIA AND THE VISION WAS 20/50.

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

  MAUDE report 12778916 ↗
• InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT HAD INTOLERABLE GLARE AT NIGHT MAKING IT WHERE SHE COULD NOT DRIVE AT NIGHT AND NOTICED MORE FLOATERS. SCHEDULED TO HAVE A VITRECTOMY TO GET RID OF THOSE. IOL EXPLANTED AND REPLACED WITH A MONOFOCAL LENS AND FLOATERS HAVE IMPROVED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 12447507 ↗
• InjuryMar 23, 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 BLURRED VISION, NEAR VISION IS NOT AS GOOD AS EXPECTED, AND IS NOT HAPPY. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 11552050 ↗