AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652415996), received between Jun 23, 2021 and May 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Application Program Problem: Power Calculation Error” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2022Application Program Problem: Power Calculation Error; Malposition of Device; Application Program Problem: Power Calculation Error; Malposition of Device

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DOUBLE VISION AND PROBLEMS FOCUSING WHICH WAS DISCOVERED THE SAME DAY AS IT WAS IMPLANTED. THE SURGEON'S OPINION THE AXIS WAS OFF FOR THE IOL. THE SURGEON WAS ROTATED THE IOL. ALSO THE PATIENT HAD PRK (PHOTOREFRACTIVE KERATECTOMY) PROCEDURE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AND SYMPTOMS WERE RESOLVED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 14428614 ↗
• MalfunctionJun 23, 2021Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  ADDITIONAL INFORMATION WAS RECEIVED IN THE FOLLOW UP, IN THE PHOTO REVIEW THE SINGLE IMAGE OF A DILATED PUPIL WAS FOCUSED BELOW THE ANTERIOR SURFACE. SEVERAL GLOBULAR SHAPES WERE IMAGED FROM THE CENTER OF THE IOL EXTENDING FROM THE 11 O'CLOCK THROUGH THE 2 O'CLOCK POSITION. THE PRESENTATION OF THESE SHAPES WERE TOO LARGE TO BE CONSIDERED TO BE MICROVACUOLES. THESE ARE MORE INDICATIVE OF INFLAMMATORY CELLS BUT DIFFICULT TO DETERMINE THE LOCATION OR THE ETIOLOGY OF THESE DEPOSITS.

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

  MAUDE report 12050551 ↗