AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380652357838), received between May 7, 2021 and Jan 12, 2026 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Failure to Deliver; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, RESISTANCE WAS ENCOUNTERED WITH A HARD STOP WHILE TURNING THE COMPANY INJECTOR. THE PROCEDURE WAS NOT COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED UPON SUBSEQUENT INSPECTION, A DENT WAS IDENTIFIED ON THE IOL, NECESSITATING CANCELLATION OF THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049993 ↗
• MalfunctionOct 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED WITH NO NOTCHED FORCEPS, WHEN THE LENS INSERTED AND OPENED, THERE WAS A CRACK IN THE MIDDLE OF THE LENS. LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM AND THERE WAS NO MEDICAL INTERVENTION HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350763 ↗
• MalfunctionFeb 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS HAD A SCRATCH ON IT. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS IMPLANT WAS INJECTED INTO THE CAPSULAR BAG, WITH NO COMPLICATIONS BUT ONCE IN PLACE IT WAS NOTED THAT THERE WAS A CENTRAL CRACK THROUGH THE INTRAOCULAR LENS, IT HAD FOLDED SO IT ODDLY COMPACTED THROUGH THE INJECTOR. DOCTOR FELT THAT THE MOST LIKELY CAUSE OF THIS WAS NEW NURSING STAFF THAT MAY HAVE EITHER NOT PUT ENOUGH OPHTHALMIC VISCOSURGICAL DEVICES (OVD) IN THE INJECTOR OR PUSHED THE INJECTOR PLUNGER TOO RAPIDLY TO ADVANCE THE LENS PRIOR TO IMPLANTING. THE LENS SHOULD HAVE BEEN AT NORMAL ROOM TEMPERATURE. THE LENS DID SIT IN THE CARTRIDGE FOR PROBABLY ABOUT 30-45 SECONDS PRIOR TO IMPLANTATION. DOCTOR DID NOT FEEL THERE WAS ANY HARM DONE TO THE PATIENT. THE LENS WAS CUT IN HALF, REMOVED AND REPLACED WITH A SIMILAR LENS AT THE TIME OF THE INITIAL PROCEDURE. THE PATIENT HAS DONE WELL SINCE THAT WITH NO COMPLICATIONS. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 1 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21394289 ↗
• MalfunctionDec 11, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN OPHTHALMOLOGIST REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE IOL BENT INCORRECTLY BY THE PISTON AND WAS DAMAGED. THERE WAS NO IMPACT ON THE PATIENT. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18300715 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT HAD A HISTORY OF MILD DRY EYE AND INTENSE PULSED LIGHT (IPL) WAS DONE FOR THE DRY EYE AND YAG PROCEDURE WAS DONE ON THE RIGHT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

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

  MAUDE report 18159774 ↗
• MalfunctionOct 13, 2023Defective Device; Failure to Eject; Defective Device; Failure to Eject

  A NURSE REPORTED WITH A DESCRIPTION OF DAMAGED INTRAOCULAR LENS (IOL) DURING THE CASE, ISSUE WAS WITH INSERTION AND GETTING STUCK IN THE WOUND.

  Patient problems: Insufficient Information

  MAUDE report 17931840 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BILATERAL NEGATIVE DYSPHOTOPSIA POSTOPERATIVELY. THE SURGEON IMPLANTED THE PIGGYBACK IOL (SULCOFLEX) IN THE RIGHT EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16052142 ↗
• MalfunctionNov 5, 2022Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15740863 ↗
• InjuryFeb 4, 2022Crack; Crack

  A PHYSICIAN REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A CRACK WAS OBSERVED ON THE LENS. DURING THE REPLACEMENT OF THE LENS THE POSTERIOR CAPSULE WAS RUPTURED AS A RESULT THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO PERFORM VITRECTOMY. THE LENS WAS REMOVED IN THE SAME PROCEDURE AND THERE WAS NO EFFECT ON THE PATIENT'S VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 13448940 ↗
• InjuryJun 24, 2021Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A HAPTIC WAS SEEN TO BE WARPED UPON OPENING THE LENS. THE PHYSICIAN THOUGHT THE LENS COULD BE USED AS THE OPTIC WAS FINE. UPON INSERTING THE IOL, THE HAPTIC CAUSED AN IMMEDIATE POSTERIOR CAPSULE RUPTURE. THE IOL HAD TO BE REMOVED AND REPLACED WITH A THREE PIECE LENS. A VITRECTOMY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12061320 ↗
• MalfunctionJun 11, 2021Crack; Crack

  A PHYSICIAN REPORTED THAT, DURING THE IMPLANTATION OF INTRAOCULAR LENS (IOL) IT WAS OBSERVED THAT CRACKED IOL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984515 ↗
• MalfunctionMay 7, 2021Crack; Crack

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A CRACK WAS FOUND AT THE CENTER PART OF THE IOL. THE LENS WAS EXCHANGED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789411 ↗