AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380652357814), received between Nov 24, 2021 and Dec 12, 2025 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Opacification” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Material Twisted/Bent; Material Twisted/Bent

  A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, IOL HAPTIC COMES WITH DAMAGE TO ONE OF ITS DISTAL ENDS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING CATARACT SURGERY FOR LEFT EYE WAS SCHEDULED AND COMPLETED ON SAME DAY. THE WAS NO PATIENT HARM AND SYMPTOMS WERE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788357 ↗
• MalfunctionNov 6, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DETACHED FROM THE OPTICAL PART OF THE LENS, MAKING IT IMPOSSIBLE TO IMPLANTATION. THERE WAS NO PATIENT INVOLVEMENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485109 ↗
• InjuryJul 30, 2025Material Opacification; Material Deformation; Material Opacification; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT IS HAVING A FURTHER SURGEON CONSULTATION FOR ANOTHER OPINION.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 22661398 ↗
• InjuryJul 30, 2025Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING BASED ON RECENT VISIT OF PATIENT SURGEON STATED LENS WAS NOT OPACIFIED AND HAS RECOMMENDED TO PROCEED WITH YAG.

  Patient problems: Posterior Capsule Opacification

  MAUDE report 22661396 ↗
• MalfunctionApr 2, 2025Failure to Deliver; Failure to Deliver

  A PHARMACY STAFF REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE INJECTOR. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21755890 ↗
• MalfunctionFeb 18, 2025Scratched Material; Scratched Material

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE SCRUB NURSE PUSHED THE PLUNGER BEYOND THE LENS, IT WAS DECIDED THAT THE LENS WAS LIKELY DAMAGED AS ON RETRACTING THE PLUNGER, LENS WAS LIKELY DAMAGED AS ON RETRACTING THE PLUNGER, IT WAS SLIGHTLY GRAINY ON THE LENS IN PULLING IT POSTERIORLY IN THE INJECTOR. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21402138 ↗
• MalfunctionNov 29, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A HEALTHCARE PROFESSIONAL REPORTED THAT, SIX MONTHS AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS HAD GLISTENING. THE LENS STILL REMAINS IN THE PATIENT'S EYE. THE VISUAL ACUITY OF PATIENT WAS DECREASED BUT PATIENT WAS NOT DISSATISFIED. THE PHYSICIAN IS CURRENTLY WAITING TO SEE IF THE LENS NEEDS TO BE EXPLANTED.

  Patient problems: Blurred Vision

  MAUDE report 18225536 ↗
• MalfunctionAug 18, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT, SAMPLE RECEIVED FOR THIS FILE. IT HAS NOT BEEN OPENED. THE NOTE ON THE ATTACHMENT STATES THE WRONG LENS WAS DELIVERED. THIS IS NOT A PRODUCT MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 17575746 ↗
• MalfunctionApr 26, 2023Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE CARTRIDGE WHILE THE LENS WAS BEING PLACED AND THE TIP OF THE LENS INJECTOR BROKE OFF THE UPPER HAPTIC OF THE LENS. THE LENS AND ADHERED IT TO THE LOWER HAPTIC, AND THE LOWER LEFT SIDE OF THE LENS WAS BROKEN. THE IMPLANTED LENS WAS CUT INTO SMALL PIECES BY THE DOCTOR AND REPLACED WITH A NEW LENS. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814660 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), SHE SEES RAYS OF LIGHT IN BOTH EYES. THE DOCTOR HAD INFORMED THAT SHE WOULD IMPROVE IN AROUND 15 TO 20 DAYS, BUT SHE INFORMED THAT THE RAYS REMAIN, MAINLY AT NIGHT, MAKING IT DIFFICULT TO SEE WHEN DRIVING. SHE ALSO REPORTED THAT, SHE SAW A LINE SIMILAR TO "AN EYELASH OR HAIR", INTERFERING WITH HER VISION. SHE ALSO INFORMED ABOUT HER EYES FEEL VERY DRY, DIFFICULTY SEEING FAR AND NEAR, DIFFICULTY LOOKING IN THE MIRROR AND THAT FOR READING SHE NEEDED TO USE HER OLD GLASSES TO FOCUS ON THE LETTERS. 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); Retinal Tear; Visual Disturbances

  MAUDE report 16503653 ↗
• MalfunctionDec 21, 2022Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT LENS FOUND TO BE FAULTY. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 16023727 ↗
• InjuryJul 29, 2022Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLARE, HALOS, UNABLE TO SEE TO DRIVE, CAN NOT SEE DISTANCE AND GAVE HER GLASSES. THE PATIENT CAN SEE CLEARLY AT NEAR. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15130977 ↗
• InjuryJul 29, 2022Material Opacification; Adverse Event Without Identified Device or Use Problem; Material Opacification; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED GLARE, HALOS, UNABLE TO SEE TO DRIVE, CAN NOT SEE DISTANCE AND GAVE HER GLASSES. THE PATIENT CAN SEE CLEARLY AT NEAR. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 15130912 ↗
• MalfunctionJul 14, 2022Scratched Material; Scratched Material

  A NURSE REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, A SCRATCH ON LENS WAS NOTICED AFTER IT WAS IMPLANTED. THE SCRATCHED LENS WAS REPLACED DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15013029 ↗
• MalfunctionJun 27, 2022Defective Device; Defective Device

  A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF THE INTRAOCULAR LENS (IOL), A DEFECT WAS NOTED ON THE LENS. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14826098 ↗
• InjuryMar 28, 2022Break; Break

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BROKEN HAPTIC WAS FOUND AFTER IMPLANTING THE LENS IN THE EYE. THE BROKEN IOL WAS LEFT IN THE EYE BECAUSE THEY DIDN'T HAVE A REPLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AND RECEIVED STATED THAT LENS WAS EXPLANTED AND THE PATIENT WAS GOOD. THE LENS WAS REPLACED WITH ANOTHER LENS, SAME DIOPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928296 ↗
• MalfunctionNov 24, 2021Scratched Material; Failure to Eject; Scratched Material; Failure to Eject

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS ADVANCED WITH THE INJECTOR, THE LENS BECAME BLOCKED AT THE END OF THE CARTRIDGE AND PROGRESS COULD NOT BE MADE. THE LENS WAS REMOVED FROM THE CARTRIDGE AND ALLOWED TO STAND IN SOLUTION UNTIL IT UNFOLDED. THEN IT WAS INJECTED WITH ANOTHER CARTRIDGE NORMALLY AND SOME MARKS WERE NOTICED ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867443 ↗