AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652357630), received between Apr 13, 2023 and Oct 22, 2024 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionOct 22, 2024Device Damaged Prior to Use; Defective Device; Material Split, Cut or Torn; Device Damaged Prior to Use; Defective Device; Material Split, Cut or Torn

  A NURSE REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS OPTIC WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20511580 ↗
• InjuryFeb 13, 2024Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DIPLOPIA AND CANNOT SEE CLEARLY. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS DISLOCATED IOL AND HAPTIC DID NOT OPEN THE RIGHT WAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT HAD MONOCULAR DIPLOPIA AND BLURRED VISION.

  Patient problems: Blurred Vision; Diplopia/Double Vision

  MAUDE report 18694740 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MILD INFLAMMATION, MILD EXUDATIVE MEMBRANE AROUND IOL AND RECOVERED WITH MEDICATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE DIAGNOSIS AS VITREOUS INFLAMMATION AND THE PATIENT HAD CONJUNCTIVAL INFLAMMATION, AQUEOUS CELL PRESENT, AQUEOUS FIBRIN PRESENT. THE PATIENT SYMPTOMS WERE RESOLVED BUT VITREOUS FLOATERS WERE PRESENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Fibrosis; Inflammation; Vitreous Floaters

  MAUDE report 17259145 ↗
• InjuryMay 23, 2023Adverse 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 VISION HAS GOTTEN WORSE SINCE SURGERY. THE PATIENT REPORTED THAT SINCE SURGERY, IT'S NEVER BEEN QUITE RIGHT. THE PATIENT TRIED DIFFERENT THINGS, DOCTOR GAVE GLASSES TO CORRECT REMAINING ASTIGMATISM, WHICH HELPED WITH PERSISTENT HEADACHE BUT HASN'T HELPED WITH VISION. DISTANCE VISION IS NOT GREAT, BUT ONLY HAS 20/70 VISION FOR READING BASED ON APPOINTMENT TODAY. PATIENT REPORTS THAT HIS SURGEON DOES NOT KNOW WHAT ELSE TO DO, AND THE PATIENT DOES NOT TRUST HIS SURGEON. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE PATIENT HAD LIMITED DEPTH PERCEPTION, TROUBLE NIGHT DRIVING, STARBURSTS. THE SURGEON ALSO STATED THAT MULTIFOCAL INTOLERANCE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 12 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. THE SYMPTOMS WERE RESOLVED TO THE PATIENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 16983261 ↗
• MalfunctionApr 13, 2023Failure to Advance; Failure to Advance

  A NURSE REPORTED THAT, THE LENS DID NOT COME OUT OF THE INSERTION DEVICE EVEN WITH ASSISTANCE. THE TEAM DOESN'T HAVE AN IDEA WHETHER THE FAULT WAS DUE TO CARTRIDGE OR DUE TO IOL. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735362 ↗