AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652415972), received between Jun 30, 2021 and Aug 21, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 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 EXPERIENCED BLURRY VISION, CLINICAL REASON BEING DECREASED CONTRAST SENSITIVITY UNACCEPTABLE NEAR VISION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17583577 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT'S VISION WAS NOT CLEAR AND DID NOT TOLERATE. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT COMPLAINED THAT VISION WAS HAZY AND NOT TO HIS SATISFACTION AT THE 6TH DAY POST OP.

  Patient problems: Blurred Vision

  MAUDE report 14621747 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT A PATIENT IS UNHAPPY WITH OVERALL VISUAL RESULTS FOLLOWING INTRAOCULAR (IOL) LENS IMPLANTATION IN BOTH EYES. THE PATIENT IS EXPERIENCING GLARE, FOG, HALOS AND DAILY HEADACHES. DISTANCE VISION AND NEAR VISION ARE NOT GREAT AND SHE IS HAVING TROUBLE DOING NEAR WORK; SHE IS UNABLE TO SEE TO READ WELL AND IS HAVING TROUBLE DRIVING AT NIGHT DUE TO GLARE. THE PATIENT REQUESTED A LENS EXCHANGE. THE SURGEON EVALUATED AND RECOMMENDED YAG LASER CAPSULOTOMY, BOTH EYES FOR POSTERIOR CAPSULE OPACITY (PCO) AND NOTED THAT THE PCO IS THE CAUSE FOR THE DECREASED VISION.

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

  MAUDE report 12481483 ↗
• InjuryJun 30, 2021Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material; Device Dislodged or Dislocated; Device Contamination with Chemical or Other Material

  INFORMATION RECEIVED VIA SURGEON ON (B)(6) 2021 CONSUMER COMPLAINED OF GLARE IN BOTH EYES. VISION HAD DROPPED TO 20/25 OU. RETURNED 1 WEEK LATER AND FELT LIKE HIS VISION WAS WORSE AFTER YAG AND WAS DOCUMENTED AT 20/30. PATIENT WAS EXAMINED AND NOTED SOME SPOTS AND MILD HAZE/PC WRINKLES. DOCTOR PERFORMED A YAG PC BUT NOTED AFTERWARDS THAT THE SPOTS ON THE IOL. THERE WERE SPOTS ON THE LEFT IOL. PATIENT RETURNED 1 WEEK LATER WITH NO IMPROVEMENT IN VISION OR SYMPTOMS. DEPOSITS WERE STILL PRESENT. ATTEMPTED TO DO LOW-POWER YAG JUST ANTERIOR TO IOL OS WITH SOME MILD SUCCESS. WAS ABLE TO YAG AWAY SOME OF THE SPOTS BUT AVOIDED THE CENTRAL SPOT. IT WAS REPORTED BY SURGEON THAT TORIC LENS ROTATED AFTER SURGERY AND WAS REPOSITIONED 1 MONTH LATER. THIS FILE REPRESENTS LEFT EYE. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12094939 ↗