AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380652357692), received between Apr 30, 2021 and May 27, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 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 RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19400413 ↗
• MalfunctionDec 28, 2023Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE IOL HAD A CENTRAL AND PERIPHERAL PLASTIC MARK THAT COULD NOT BE MANIPULATED. IT LOOKED AS IF THE CARTRIDGE RELEASED PLASTIC. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18408074 ↗
• InjuryJul 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANTATION THE VISUAL ACUITY WAS ONLY 30%. THE PATIENT ALSO HAD TO UNDERGO A YAG LASER, BUT DESPITE IT SHE HAD A VISION OF MAXIMUM 40%. AS A RESULT, THE SURGEON DECIDED TO IMPLANT AN ADD-ON LENS BECAUSE THE PATIENT WAS VERY UPSET. THE PATIENT CAME BACK FOR A FOLLOW UP AND THE VISION WAS 60% WITHOUT GLASSES, FOR WHICH UNFORTUNATELY THE PATIENT WAS STILL NOT SATISFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 17411762 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD COMPLAINED OF BOTHERSOME HALO AND GLARE AROUND LIGHTS WHILE DRIVING AT NIGHT. IT WAS FURTHER CLARIFIED THAT THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA AND PATIENT WAS DISSATISFIED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15975667 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEVERE VISUAL DISTURBANCE. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS NON-ADAPTATION TO OPTIC RINGS. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S ISSUES WERE RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Visual Impairment

  MAUDE report 15714994 ↗
• InjuryOct 28, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE CLOSE UP IS GONE AND ALSO NEED READING GLASSES FOR CLOSE UP WHICH DID NOT NEEDED, RIGHT EYE IS MORE BLURRY, NO NIGHTTIME VISION AT ALL AND PATIENT FEELS DOCTOR GAVE THE WRONG PRESCRIPTION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS TURNING COLORS IN MY EYES AND BEING VISIBLE AND MOVING AROUND IN MY EYES. IN MY RIGHT EYE THE IMPLANTED LENS JIGGLES. ALSO THERE ARE LIGHT REFLECTIONS THAT MAKES ME LOOK LIKE A LIZARD IN PUBLIC, NO NIGHT VISION ANYMORE CANNOT DRIVE ANYMORE AT NIGHT ONLY IN FAMILIAR AREA, DISTANCE WAS BLURRY FROM THE START. CLOUDY SPOT THAT I WAS SEEING SHE PERFORMED A PROCEDURE UNDER THE CUFF WHICH SHE PUT SLITS ON MY EYEBALL WHICH DID NOTHING TO MY VISION. LYING DOWN WATCHING TV OR JUST LOOKING MY VISION IS TOTALLY BLURRY, THEN I HAVE TO CLOSE ONE EYE AND IT GOES ONE AND OFF CLEAN THEN NOT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15688748 ↗
• MalfunctionSep 14, 2022Scratched Material; Scratched Material

  AN OPHTHALMOLOGIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ENCOUNTERED SCRATCH IN THE MIDDLE OF THE OPTIC AND IT AFFECTED THE VISION. THERE WAS PATIENT CONTACT OBSERVED AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY EXPLANTING THE LENS DURING INITIAL PROCEDURE AND REPLACING IT WITH THE NEW SAME MODEL LENS.

  Patient problems: Blurred Vision

  MAUDE report 15416607 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED, STATING THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. AND THERE WAS NO PATIENT HARM.

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

  MAUDE report 12713465 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT'S MID-RANGE VISION DID NOT SHOW MORE THAN 0.3. THE IOL WAS EXCHANGED AT A DIFFERENT HOSPITAL. THE SAMPLE WILL NOT BE RETURNED.

  Patient problems: Blurred Vision

  MAUDE report 11752200 ↗