AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652390545), received between May 21, 2020 and Jan 9, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of 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.

• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT IS NOT SEEING WELL AND THE VISION IS NOT FOCUSING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE 1 OF 2. ADDITIONAL INFORMATION IS NOT EXPECTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16121434 ↗
• InjurySep 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT¿S VISION DROPPED FROM 1.0 TO 0.2 DOWN. THE SURGEON SEEN THE HAPTIC HAS BEEN PLACED ABOVE THE IRIS AND THE ALSO THOUGHT THAT THERE IS A POSSIBILITY OF EYE STRUCTURE HAS WEAKENED. THE LENS EXCHANGED IN A SECONDARY PROCEDURE.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 15349473 ↗
• InjuryFeb 23, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DISPLACED. THE PATIENT EXPERIENCED BLURRY DOUBLE VISION/DIPLOPIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13582925 ↗
• InjuryMar 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED, AFTER THE INTRAOCULAR LENS WAS IMPLANTED THERE WAS AN UNEXPLAINED CAPSULE RUPTURE IN THE UPPER TEMPORAL REGION. THE IMPLANT WENT VERTICAL AND THE SURGEON HAD TO REMOVE IT. THE PHYSICIAN REPORTED THAT THERE WAS NO ZONAL FRAGILITY, INITIALLY OR AFTER THE SURGERY. ADDITIONAL INFORMATION IS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 11396167 ↗
• MalfunctionMay 21, 2020Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING DURING AN OBJECTIVE EXAMINATION OF THE EYE, NUMEROUS VACUOLES WERE OBSERVED IN THE OPTICAL PART OF THE LENS, WHICH HAD NEWLY FORMED IN THE MATERIAL OF THE INTRAOCULAR LENS IN THE RIGHT EYE THE SO-CALLED GLISTENING. THE PATIENT HAS NO SUBJECTIVE PROBLEMS. OUTCOME OF INCIDENT WAS REPORTED AS WITHOUT DETERIORATION OF HEALTH.

  Patient problems: Visual Disturbances

  MAUDE report 10079368 ↗