AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652390002), received between Apr 20, 2021 and Jan 22, 2025 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2025Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF LOADING THE LENS INTO THE CARTRIDGE, THE SURGEON NOTICED THAT SHE HAD A DAMAGED HAPTIC WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS NEVER BEEN IN CONTACT WITH THE PATIENT AND PATIENT WAS NEVER AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206647 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION IN THE LEFT EYE THE PATIENT HAD EXPERIENCED SLIGHT DIFFICULTIES, ESPECIALLY WHEN IT COMES TO DRIVING. THE PHYSICIAN DENIED CONSENT TO BE CONTACTED REGARDING THIS CASE BECAUSE HE BELIEVES THAT IT WAS NOT A SIDE EFFECT, BUT A PLANNED APPROACH TO THE PATIENT AND THE OPERATION AND EVERYTHING WAS PERFECTLY NORMAL AND WITHOUT COMPLICATIONS.NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16929046 ↗
• MalfunctionFeb 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A HEALTH CARE PROFESSIONAL DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FIRST INSERTED WAS IN NOT POSITION AND THEN REMOVED. THEN THE PHYSICIAN TRIED THE ANOTHER COMPANY LENS IT WAS ALSO DID NOT STAY IN PLACE, HENCE REPLACED WITH ANOTHER NON COMPANY LENS.

  Patient problems: Insufficient Information

  MAUDE report 16359616 ↗
• MalfunctionOct 18, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED DURING IMPLANTATION AND THEN IT WAS REMOVED AND REPLACED WITH SAME MODEL LENS. THERE WAS NO PATIENT HARM. THE PATIENT WAS NOT HOSPITALIZED IN RESPONSE TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15622227 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT APPROXIMATELY AFTER A MONTH OF IMPLANTATION, THE LENS WAS EXPLANTED DUE TO PATIENT WAS NOT BEING SATISFIED WITH THEIR VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14875563 ↗
• MalfunctionMay 30, 2022Scratched Material; Scratched Material

  AN OPERATION ROOM STAFF REPORTED THAT REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS IN THE CUSTOMER'S EYE, A SCRATCH / LINE / SIMILAR MARK WAS VISIBLE IN THE CENTER OF THE LENS. THE LENS HAD TO BE CUT OFF AND TAKEN OUT OF THE CUSTOMER 'S EYE AND A NEW LENS WAS INSTALLED IN ITS PLACE. THERE WAS NO PATIENT HARM INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT, AT THE END OF THE OPERATION, THE DOCTOR NOTICED A MARK ON THE INSERTED LENS, THE INSERTED LENS WAS REMOVED AND REPLACED IT WITH A NEW ONE. IN OTHER WORDS, FROM THE CLIENT'S POINT OF VIEW, THE PROCEDURE TOOK A LITTLE LONGER, BUT DID NOT ACTUALLY REQUIRE ANY ''ADDITIONAL TREATMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14544303 ↗
• MalfunctionMar 28, 2022Defective Device; Defective Device

  A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEFECTIVE LENS WAS NOTED. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13931561 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO TOLERATE HALOS/ RINGS WITH STARBURSTS AROUND LIGHTS IN THE DAY. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13858127 ↗
• MalfunctionDec 7, 2021Scratched Material; Scratched Material

  A MATERIALS COORDINATOR REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS SCRATCHED. THE LENS WAS CUT AND REMOVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12954201 ↗
• MalfunctionJun 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING ABOUT THE PATIENT EXPERIENCED DOUBLE VISION AT DISTANCE AND WAS CORRECTED WITH GLASS -0.50D AS A RESULT THE DOUBLE VISION WAS LESS.

  Patient problems: Visual Impairment

  MAUDE report 12023565 ↗
• InjuryApr 20, 2021Break; Malposition of Device; Break; Malposition of Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE OF THE RIGHT EYE, DECENTRATION OF THE IOL WAS OBSERVED DURING THE POSTOPERATIVE PERIOD. THE IOL WAS ROTATED THEN FOUND TO BE OFF CENTER AGAIN WITH PATIENT REPORT OF POOR VISION IN ALL DISTANCES. THE IOL WAS EXPLANTED. THE EXPLANTED IOL WAS BROKEN AT THE OPTIC-HAPTIC JUNCTION. THE IOL WAS REPLACED WITH A MONOFOCAL IOL. THE PATIENT IS SATISFIED. FURTHER INFORMATION HAS BEEN REQUESTED; HOWEVER, ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Blurred Vision

  MAUDE report 11697291 ↗