AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652357807), received between Mar 8, 2021 and Jun 20, 2025 — classified as 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WAS BLURRY VISION. CLINICAL REASON FOR EXPLANT WAS WRONG IOL POWER. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 01 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22302162 ↗
• InjuryFeb 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON ADVISED THE LENS HAD MARK, ONE CRACKED IN THE INJECTOR. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE UNSPECIFIED BACKUP LENS. THERE WAS A PATIENT HARM. THE PATIENT WAS PRESCRIBED WITH THE ACETAZOLAMIDE FOR 3 DAYS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT ON (B)(6) 2025 THE PATIENT WAS SEEN FOR AFTERCARE AND WAS FOUND TO HAVE LEFT EYE EDEMA WITH FOLDS IN DESCEMET'S MEMBRANE. THE PATIENT WAS COMPLETED ORAL MEDICATION COURSE AND IS CONTINUING WITH ROUTINE EYE DROPS AND SCHEDULED AFTERCARE APPOINTMENTS.

  Patient problems: Corneal Edema; Insufficient Information

  MAUDE report 21431381 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRY VISION. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 4 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS WRONG IOL POWER AND PATIENT WAS TOO MYOPIC WITH ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20641439 ↗
• InjuryOct 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED NEGATIVE DYSPHOTOPSIA. A FISSURE WAS NOTED ON THE IOL. THE PATIENT VISION HAD BEEN AFFECTED. THE LENS WAS EXPLANTED AND IMPLANTED WITH SAME MODEL LENS. THE SYMPTOMS WERE RESOLVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20357562 ↗
• MalfunctionAug 7, 2024Failure to Deliver; Failure to Eject; Failure to Deliver; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IMPLANT HAS NOT COME OUT OF THE CARTRIDGE OR HAS NOT UNFOLDED PROPERLY. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19929551 ↗
• InjuryJun 11, 2024Material Discolored; Material Discolored

  A PHARMACIST REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS ANTERIOR SURFACE WITH DEPOSITS THAT ARE CAUSING SIGNIFICANT VISUAL IMPAIRMENT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING SIGNIFICANT VISUAL DECLINE (4/10) WHEREAS OPERATIVE RECOVERY WAS VERY GOOD (10/10). DEPOSITS ON THE ANTERIOR SURFACE OF THE IMPLANT, DESPITE GOOD OPENING OF THE ANTERIOR RHEXIS.MEASURES WERE TAKEN BY CLEANING THE ANTERIOR SURFACE OF THE IMPLANT WITH MINIMAL YAG LASER POWER. LAB DATA: BEST CORRECTED VISUAL ACUITY PRE-OP? 6/10WEAK PARINAUD 3 - BEST CORRECTED VISUAL ACUITY POST-OP? 10/10 PARINAUD 1.5. - BEST PREOPERATIVE UNCORRECTED VISUAL ACUITY? 4/10 WEAK. - POSTOPERATIVE UNCORRECTED VISUAL ACUITY? 9/10 PARINAUD 2 ; CYCLOPLEGIC REFRACTION -0.25 (-0.50 À 60°) 10/10.

  Patient problems: Visual Impairment

  MAUDE report 19509863 ↗
• MalfunctionNov 10, 2023Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS BROKEN WHEN IT CAME OUT OF CARTRIDGE. THE LENS WAS REMOVED AND REPLACED WITH A NEW ONE IN AN INITIAL PROCEDURE. 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 18109719 ↗
• InjuryOct 23, 2023Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INTRODUCED WITHOUT PRESSURE INTO THE PATIENT'S EYE CHAMBER AND WHEN IT WAS DEPOSITED, IT RELEASED A DUST, MAKING IT SEEM LIKE THE LENS WAS PEELING OFF AND RELEASED A ITS HAPTIC INSIDE THE EYE, WHICH THE SURGEON TRIED TO FIX THE LENS IN POSITION AND COULD NOT, SURGEON HAD TO PROCEED TO CUT IT FOR ITS EXTRACTION DURING INITIAL PROCEDURE, CAUSING A LONGER PERIOD OF SURGERY AND CONCERN FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS DAMAGE TO THE PATIENT, THE PATIENT STILL HAS VERY SEVERE EDEMA IN THE CORNEA AND ANTERIOR CHAMBER, DETACHMENT OF DECREMENT MICROPARTICLES. THE PROBLEM OCCURRED DURING CATARACT SURGERY WHEN THE LENS WAS IMPLANTED IN THE ANTERIOR CHAMBER. WHEN THE IOL FINISHED ENTERING, IT RELEASED DUST AND ONE OF ITS HAPTICS BECAME DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS.

  Patient problems: Corneal Edema; Eye Injury

  MAUDE report 17984911 ↗
• MalfunctionOct 20, 2023Failure to Eject; Failure to Eject

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS BLOCKED IN INJECTOR DESPITE THE USUAL PROTOCOL AND THE VISCOUS PUT. LENS WAS NOT IMPLANTED, NO PATIENT IMPACT. THEY TOOK BACK-UP LENS, IMPLANTED WITHOUT ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976710 ↗
• MalfunctionOct 20, 2023Positioning Failure; Defective Device; Positioning Failure; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, WHEN THE SURGEON ATTEMPTED TO IMPLANT THE LENS IT BECAME STUCK IN THE CORNEAL INCISION. THE PHYSICIAN THEN REMOVED IT TO REFOLD AND ATTEMPT TO REINSERT, AND NOTED A DAMAGE TO THE LENS AND HENCE THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17975814 ↗
• MalfunctionJul 7, 2023Defective Device; Scratched Material; Defective Device; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS DEFORMED AND SCRATCHED WERE FOUND ON THE LENS. THE DAMAGED LENS IMPLANTED IN THE PATIENT'S EYE HAD TO BE REMOVED FROM THE EYE AND THE DURATION OF THE SURGICAL PROCEDURE WAS THEREFORE PROLONGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17277183 ↗
• MalfunctionApr 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE GLISTENINGS ON THE LENS WERE NOTED. THERE WAS NO PATIENT HARM, AND NO SURGICAL INTERVENTION WAS REQUIRED; THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE PHYSICIAN FURTHER CLARIFIED GLISTENING AS A MATERIAL DEFECT, HE HAS NO SLIT LAMP IMAGES, AND NO EXPLANTATION WAS PLANNED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR FIVE OF SIX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674965 ↗
• MalfunctionApr 4, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE GLISTENINGS ON THE LENS WERE NOTED. THERE WAS NO PATIENT HARM, AND NO SURGICAL INTERVENTION WAS REQUIRED; THE IOL REMAINS IMPLANTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING THE PHYSICIAN FURTHER CLARIFIED GLISTENING AS A MATERIAL DEFECT, HE HAS NO SLIT LAMP IMAGES, AND NO EXPLANTATION WAS PLANNED. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR SIX OF SIX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674634 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED THAT THE PATIENT'S SYMPTOM WAS RESOLVED. THE LENS WAS EXCHANGED WITH OTHER COMPANY IOL.

  Patient problems: Visual Impairment

  MAUDE report 12707637 ↗
• InjurySep 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT EXPERIENCED HALO AROUND LIGHTS. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR CLINICAL REASON OF INTOLERANCE OF DYSPHOTOPSIA FROM MULTIFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12422898 ↗
• InjuryAug 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGICAL TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR QUALITY VISION AND COULD NOT TOLERATE TRIFOCAL VISION. THE IOL WAS EXCHANGED IN SECONDARY PROCEDURE WITH DIFFERENT MODEL APPROXIMATELY 3 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12339042 ↗
• InjuryJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURES, AFTER TWO ATTEMPTS TO INSERT THE LENS IT WAS FOUND THAT HAPTIC WAS DETACHED FROM THE LENS. THE INCISION WAS WIDENED FOR THE IOL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Injury

  MAUDE report 12057305 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT REPORTED GLARE FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: Visual Disturbances

  MAUDE report 11519973 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A LEFT EYE CATARACT PROCEDURE WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT REPORTED HALOS AND GLARE IN BOTH EYES. NIGHT DRIVING IS "EXTREMELY DIFFICULT."YAG LASER CAPSULOTOMY WAS PERFORMED. THE PATIENT RETURNED FOR A FOLLOW UP EVALUATION AND REPORTED "VERY UNCOMFORTABLE WITH THE HALOS, CANNOT LIVE WITH." THE PATIENT WISHES TO HAVE THE LENSES EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENTS LARGE PUPIL SIZE CONTRIBUTES TO THE REPORTED SYMPTOMS OF HALOS AND GLARE. TINTED GLASSES WERE PRESCRIBED FOR DRIVING BUT DEEMED INEFFECTIVE.

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

  MAUDE report 11438405 ↗