AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652357937), received between Oct 11, 2022 and Jul 18, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• InjuryJul 18, 2023Defective Component; Adverse Event Without Identified Device or Use Problem; Defective Component; Adverse Event Without Identified Device or Use Problem

  A PHARMACIST REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LUMINOUS HALOS AND DRY EYES, THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Blurred Vision; Dry Eye(s); Halo

  MAUDE report 17343540 ↗
• InjuryApr 27, 2023Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WENT INTO THE EYE WITH A HALF BROKEN LEG. THE LENS TURNED WELL IN THE EYE, SO THE OPHTHALMOLOGIST DECIDED TO LEAVE THE LENS IN PLACE. UNFORTUNATELY FOR THE PATIENT, THE LEG IN THE EYE HAS COMPLETELY BROKEN OFF, CAUSING THE LENS TO TILT. SUBSEQUENTLY, THE OPHTHALMOLOGIST HAD TO DO A LENS EXCHANGE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE AFFECTED LENS WAS REMOVED FROM THE EYE DURING SECONDARY SURGERY AFTER 15 DAYS OF INITIAL IMPLANTATION. THE WOUND NEEDED TO BE ENLARGED WHILE REMOVING THE LENS, BUT THERE WERE NO ADDITIONAL STITCHES NECESSARY.

  Patient problems: Eye Injury

  MAUDE report 16821249 ↗
• InjuryMar 6, 2023Break; Break

  A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN WHEN OPENED THE LENS PACKAGE. THE PATIENT WAS LEFT APHAKIC AND SECOND SURGICAL ACTION WAS REQUIRED TO INSERT THE LENS WITH NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485406 ↗
• InjuryOct 11, 2022Adverse 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 EXPERIENCED POSITIVE DYSPHOTOPSIA AND NEGATIVE DYSPHOTOPSIA. SUPEROTEMPORAL FLICKERING/STROBELITE WORSE WITH ARTIFICIAL LIGHTING ESPECIALLY LED LIGHTS FROM OVERHEAD BUT SEE SOME WHEN LOOKING AT IPHONE/IPAD. WORSE WHEN STRESSED OR FATIGUED. NO IMPROVEMENT SINCE SURGERY. WORSE WITH MIOTICS TRIAL OF VUITY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15578767 ↗