AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652357685), received between Dec 28, 2021 and Nov 20, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2024Defective Component; Defective Component

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF HAPTIC ISSUE. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20737033 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL DIRECTOR REPORTED THAT AN INTRAOCULAR LENS (IOL) HAD TO BE EXPLANTED IN A SECONDARY PROCEDURE, BECAUSE THE PATIENT HAD VERY BLURRY VISUAL ACUITY AND WAS EXTREMELY UNHAPPY WITH IT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 16466151 ↗
• InjuryOct 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, PATIENT WAS ABLE TO SEE DISTANCE BUT HER CLOSE UP WAS GONE AND ALSO NEEDED READING GLASSES FOR CLOSE UP WHICH SHE DID NOT WEAR BEFORE BUT NEEDED COMPUTER GLASSES AND SHE STILL NEEDED READING GLASSES WITH THE LENSES FOR COMPUTER. SHE HAD NO NIGHT TIME VISION AT ALL ANYMORE AND IT WAS NOT BECAUSE OF HALOS FROM THE LIGHT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LEFT EYE WAS BLURRY, LENS TURNING COLORS IN HER EYES AND BEING VISIBLE AND MOVING AROUND IN HER EYES. LENS WAS MOVING AROUND IN HER EYES, ALSO THERE WERE LIGHT REFLECTIONS THAT MADE HER LOOK LIKE A LIZARD IN PUBLIC, NO NIGHT VISION ANYMORE COULD NOT DRIVE ANYMORE AT NIGHT ONLY IN FAMILIAR AREA. CLOUDY SPOT THAT SHE WAS SEEING AND SAID SHE HAD ASTIGMATISM AND PERFORMED LASER TO THE EYE. LYING DOWN WATCHING TV OR JUST LOOKING HER VISION WAS TOTALLY BLURRY, THEN SHE HAD TO CLOSE ONE EYE AND IT GOES ONE AND OFF CLEAN THEN NOT. PATIENT FELT DOCTOR GAVE THE WRONG PRESCRIPTION. ADDITIONAL INFORMATION WAS RECEIVED STATING SYMPTOMS WERE NOT RESOLVED AND PATIENT WAS NOT HOSPITALIZED AS A RESULT OF THIS EVENTS. THERE ARE TWO MEDICAL D

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15697804 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, HIS VISION WAS HORRIBLE, ALMOST FELT LIKE HIS VISION WAS LOST. A MEDICAL INTERVENTION WAS CARRIED OUT WHICH WAS NOT EXPLAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14826541 ↗
• InjuryDec 28, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE SAME LENS MODEL BUT ONE AND HALF DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.

  Patient problems: Blurred Vision

  MAUDE report 13095517 ↗