AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.270)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652357876), received between Sep 8, 2021 and Sep 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionSep 11, 2025Break; Optical Decentration; Failure to Unfold or Unwrap; Break; Optical Decentration; Failure to Unfold or Unwrap

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED THE HAPTIC WAS STUCK TO OPTIC. THE SURGEON GAVE IT TIME TO UNFOLD, AS USUAL, BUT IT DID NOT UNFOLD. HE SEPARATED IT WITH FORCEPS BUT THE HAPTIC WAS COMPLETELY SEPARATED FROM THE OPTIC. HE REMOVED THE BROKEN HAPTIC AND LEFT THE LENS IMPLANTED IN THE CAPSULAR BAG. THE PATIENT HAS ACCEPTABLE INTERMEDIATE AND DISTANCE VISION, BUT NEAR VISION WAS NOT GOOD BECAUSE THE LENS HAS BECOME DECENTERED. THE SURGEON HAS PLANNED TO EXPLANT THE LENS. THE SYMPTOMS WERE IMPROVING AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 23024069 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHARMACIST REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BILATERAL VISUAL DISCOMFORT WITH WAXY VISION AND PERSISTENT HALOS. THE LENS WAS REMOVED AND REPLACED WITH A COMPANY LENS IN A SECONDARY PROCEDURE.

  Patient problems: Halo; Visual Impairment

  MAUDE report 18594468 ↗
• InjuryDec 6, 2023Defective Component; Defective Component

  A PHARMACIST REPORTED THAT WHEN THE IOL ( INTRAOCULAR LENS) WAS INSERTED INTO THE BAG, THE HAPTICS DID NOT DEPLOY, THEY WAITED AND MANEUVERS WERE MADE TO DEPLOY THEM AND THEY WERE NOT ACHIEVED. TEMPORARY DIALYSIS OF 90 DEGREES WITH PASSAGE OF VITREOUS OCCURRED, A WIDE VITRECTOMY WAS PERFORMED THROUGH DIALYSIS, A 11 MM CAPSULAR EXPANSION RING WITH WHICH DIALYSIS WAS CONTROLLED, FINALLY THE HAPTICS EXPAND AND THE IOL REMAINS WELL CENTERED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Prolapse

  MAUDE report 18273272 ↗
• MalfunctionSep 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HEALTH PROFESSIONAL REPORTED ABOUT A AN INTRAOCULAR LENS (IOL) BEING DEFECTIVE- A BIT SPOTTY. THE PROCEDURE WAS COMPLETED WITH OTHER COMPANY LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439678 ↗