AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00380652357753), received between Mar 26, 2021 and Jun 30, 2026 — classified as 22 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EXCHANGED DUE TO THE OUTCOME AFTER THE SURGERY DID NOT MET EXPECTATIONS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT UNDERWENT SURGERY WITH COMPANY LENS IN 2020; HOWEVER, DUE TO UNSATISFACTORY VISUAL OUTCOME, THE LENS WAS EXCHANGED TO A NON COMPANY LENS.

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

  MAUDE report 25668254 ↗
• MalfunctionMar 31, 2026Failure to Deliver; Material Split, Cut or Torn

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE IMPLANT BLOCKED IN THE INJECTOR. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IMPLANT BROKE DURING ITS PROGRESSION INSIDE THE INJECTOR AND THERE WAS NO PATIENT CONTACT. SAME MODEL AND DIOPTER COMPANY LENS WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743621 ↗
• MalfunctionJan 24, 2026Break

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A RIGID IMPLANT WAS OBSERVED UPON OPENING THE BOX. THE IMPLANT BROKE CLEANLY AT THE HAPTIC DURING HANDLING. THE BACKUP LENS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173130 ↗
• MalfunctionNov 11, 2025Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO HAVE BROKEN TRAILING HAPTIC WHILE LOADING THE IOL IN THE CARTRIDGE. THERE WAS NO PATIENT CONTACT REPORTED WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523095 ↗
• InjuryJun 24, 2025Material Opacification; Particulates; Material Opacification; Particulates

  A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT WHO HAD AN INTRAOCULAR LENS (IOL) IMPLANTED APPROXIMATELY NINE YEARS AGO RECENTLY RETURNED FOR A POSTOPERATIVE EVALUATION. DURING THIS VISIT, OPACIFICATION OF THE LENS WAS OBSERVED. THE OPACIFICATION COULD NOT BE RESOLVED USING YAG LASER TREATMENT, SUGGESTING THE PRESENCE OF FOREIGN MATERIAL OR DEGRADATION OF THE LENS ITSELF.

  Patient problems: Visual Impairment

  MAUDE report 22318440 ↗
• InjuryJun 19, 2025Break; Break

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER IMPLANTING THE LENS, THE PHYSICIAN NOTICED THE HAPTIC WAS BROKEN. AS HE DID NOT HAVE THE APPROPRIATE SCISSORS TO REMOVE THE IMPLANT, HE DECIDED TO LEAVE IT IN PLACE AND DECIDED TO REFER HIS PATIENT TO ANOTHER SURGEON TO PLAN AN EXPLANTATION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF SAME MODEL. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PROCEDURE WENT VERY WELL WITH NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22292687 ↗
• MalfunctionMay 30, 2025Break; Break

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE BROKEN WHILE LOADING, WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112125 ↗
• MalfunctionMar 4, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHEN THE LENS WAS INSERTED INTO THE PATIENT'S EYE, THE HAPTIC BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21512584 ↗
• MalfunctionDec 6, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED BY INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20862881 ↗
• MalfunctionAug 15, 2024Break; Failure to Eject; Break; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THAT LENS DIDN¿T REMOVE FROM THE INJECTOR COMPLETELY, THE PLUNGER WAS REMOVED AND FRACTURE OF THE UPPER HAPTIC HANDLE OF THE LENS. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE WITH RESCUE CLAMP AND COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19990302 ↗
• MalfunctionDec 5, 2023Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS OBSERVED TO HAVE OPTICAL SCRATCHES AFTER IMPLANTATION. HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18264677 ↗
• MalfunctionNov 21, 2023Break; Device Contamination with Chemical or Other Material; Break; Device Contamination with Chemical or Other Material

  A NURSE MANAGER REPORTED THAT, A CRACK WAS VISIBLE UNDER THE MICROSCOPE ONCE THE LENS WAS IN THE EYE BAG. IN ADDITION, SOME PIGMENT WITH METALLIC REFLECTIONS WERE ALSO PRESENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18180369 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IT HAS TAKEN RATHER A LONG TIME TO ADJUST TO MY NEW VISUAL SYSTEM. IT IS RATHER POOR FOR LOOKING AT POWER POINT IN A CLASSROOM AND LOOKING AT THE TV. UNFORTUNATELY THE PATIENT NOW FEEL SHORT SIGHTED. THE PATIENT HAD REALLY STRUGGLED WITH OTHER DISTANCES. ONE OF THESE WOULD BE AT 6 M WHICH IS USED FOR ASSESSMENT OF VISUAL ACUITY. THE OPTOMETRIST INFORMS PATIENT HAD A -1 DIOPTER CYLINDRICAL ERROR IN BOTH EYES AND MODEST SPHERICAL ERRORS OF BETWEEN 0.5 AND 1.0 DIOPTER. I HAVE ALSO BEEN TOLD THAT THIS WOULD NOT BE IMPROVED BY TOP UP REFRACTIVE SURGERY TO THE CORNEA. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, VISION SERIOUSLY DEGRADED AFTER LENS IMPLANTATION. SERIOUS LOSS OF CONTRAST SENSITIVITY WITH LOSS OF ABILITY TO DRIVE DURING THE DAY WITH ADVERSE VISIBILITY CONDITIONS. INABILITY TO WORK IN CERTAIN CONDITIONS OF LOW CONTRAST WITH NON-IMAGE LIGHT ENTERING THE EYE CREATING GLARE DURING DAYLIGHT. DOUBLE VISION IN SOME CIRCUMSTANCES (VERTICAL WHITE POSTS, EDGES OF WHITE CARS, LED SIGNS). EXACERBATION OF PRE-EXISTING SYMPTOM OF FLOATERS.

  Patient problems: Halo; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 17727536 ↗
• InjuryJul 20, 2023Scratched Material; Scratched Material

  A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT COMPLAINED OF SIGNIFICANT GLARE, AND UPON EXAMINING THE LENS, THE SURGEON CONFIRMED THE PRESENCE OF A SCRATCH BETWEEN THE DIFFRACTION RINGS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 17358606 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE COMPLICATION HAPPENED UPON IMPLANTING THE LENS. A SULCUS LENS WAS USED, AND SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT, BUT NO PATIENT HARM.  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THAT THE COMPLICATION EXPERIENCED BY THE PATIENT WAS POSTERIOR CAPSULE RUPTURE. THE PHYSICIAN DID NOT HAVE STRONG EVIDENCE THAT HE SUSPECTS THE IOL.

  Patient problems: Capsular Bag Tear

  MAUDE report 17296546 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT HAD ISSUES WITH GLARE AND HALOS AND DIFFICULTY ON THE COMPUTER. PATIENT ALSO HAD STRUGGLE WITH INTERMEDIATE VISION. THE PATIENT HAD BEEN REPORTED TO BE MONITORED CURRENTLY. THERE WAS NO LENS EXCHANGE, LENS REMAINS IMPLANTED IN PATIENT'S EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 16893986 ↗
• InjuryMar 31, 2023Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, PATIENT EXPERIENCED HAZY VISION AS WELL AS LOT LIKE FLOATERS. SMALL SCRATCH ON CENTRAL BUTTON OF OPTIC WAS ALSO NOTED. ADDITIONAL INFORMATION RECEIVED STATED THAT, PATIENT'S RIGHT EYE WAS INVOLVED. THE IOL WAS EXPLANTED AND REPLACED WITH ANOTHER IOL IN A SECONDARY PROCEDURE. IN THE SURGEON'S OPINION LIKELY CONTACT WITH INSERTER OR SURGICAL INSTRUMENT CAUSED OR CONTRIBUTED TO EVENT. THERE WAS NO PATIENT HARM AFTER REMOVAL OF LENS.

  Patient problems: Visual Impairment; Vitreous Floaters

  MAUDE report 16654558 ↗
• MalfunctionMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT DURING THE LASER ASSISTED CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION HE REPORTED VACUOLES AND GLISTENINGS. PATIENT¿S VISION WAS 6/12 AT 1 DAY POSTOP AND HAPPY, AT 1 WEEK POST-OP HE HAD IMPROVED TO 6/7.5 IN THE EYE. THE SURGERY WAS COMPLETED. THE LENS REMAINS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 16598446 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD IMPROVEMENT OF HIS NEAR VISION MEASURED AS 0.4 AT 40 CM. IT WAS FURTHER REPORTED THAT EVEN AFTER SIX MONTHS POST OPERATIVE THE VISION WAS STILL POOR. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 16466572 ↗
• InjuryFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED GLARE AND VISION WAS BLURRY HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH A MONOFOCAL LENS. ADDITIONAL; INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16385647 ↗
• InjuryFeb 15, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT PATIENT¿S DIFFICULTIES RELATED TO A HIGHISH ANGLE KAPPA/ALPHA AND THUS, THE IOL CENTRATION WAS THE ISSUE WITH THE PATIENT¿S SATISFACTION.

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

  MAUDE report 16378486 ↗
• MalfunctionFeb 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT THIS WAS NOT A PATIENT IMPACTING EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16359615 ↗
• MalfunctionFeb 11, 2023Scratched Material; Scratched Material

  DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE SCRATCH WAS SEEN ON THE OPTIC. THE IOL WAS REPLACED WITH ANOTHER IOL. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359610 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 16254779 ↗
• InjuryJan 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED ISSUE WITH NIGHT DRIVING, DECREASED VISION AT NIGHT WITH HALOS AND GLARE, SHE ALSO EXPERIENCED STARBURST FROM HEADLIGHT AND TAILLIGHTS. ADDITIONAL INFORMATION HAS BEEN 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 16082902 ↗