AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652357722), received between Mar 11, 2021 and Apr 28, 2026 — classified as 13 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Failure to Fold; Product Quality Problem

  A PHARMACIST REPORTED THAT THE IMPLANT BENDS IN THE INCORRECT DIRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018747 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT BEGAN EXPERIENCING BLURRED VISION AND THE COMPLAINTS HAD PROGRESSIVELY WORSENED OVER TIME. PATIENT EXPERIENCING SIGNIFICANT VISION LOSS, ESPECIALLY AT NEAR AND INTERMEDIATE DISTANCES, WHICH PREVENTS FROM CONCENTRATING AT WORK AND CAUSES MAJOR DIFFICULTIES IN DAILY LIFE. DURING THE FOLLOW-UP DUE TO THESE ISSUES, PATIENT WAS TOLD THAT THIS WAS A TEMPORARY CONDITION. HOWEVER, PATIENT COMPLAINTS HAVE CONTINUED TO INCREASE AND STILL PERSIST. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT SEE THE KEYBOARD KEYS BLURRY AND WHEN THE ENVIRONMENT IS SLIGHTLY DIM, PATIENT CANNOT SEE AT ALL. BEFORE THE SURGERY PATIENT HAD MYOPIA AND ASTIGMATISM NOW PATIENT HAD BECOME HYPEROPIC WITH ASTIGMATISM AND NEED TO WEAR READING GLASSES TO HAVE CLEAR VISION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22993755 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MAJOR HALOS AROUND LIGHTS, CONSTANT IN ALL LIGHTING, COULD NOT TOLERATE MULTIFOCAL LENS. THE EXPLANT WAS SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS EXPLANTED AND EXCHANGED WITH ANOTHER MODEL 1 DIOPTER MORE COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS SIGNIFICANT GLARE AND INABILITY TO DRIVE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22860961 ↗
• InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED SYMPTOMS ARE STILL CONTINUING AND ALSO REPORTED THAT NEED GLASSES TO READ NEWS PAPER AND SMALL PRINTS, PATIENT EXPERIENCING BLURRY VISION AT ALL DISTANCES.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 21191160 ↗
• MalfunctionJul 2, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF TEAR IN INTRAOCULAR LENS (IOL), DURING FOLDING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE TEAR WAS NOTICED WHEN THE LENS WAS UNFOLDED IN THE EYE. DEFINITELY IT WAS A TEAR, NOT A SCRATCH, FROM THE EDGE OF THE OPTICS, HALFWAY BETWEEN THE HAPTICS. IT WAS UNKNOWN WHICH SIDE. SEEMED TO BE ABOUT 3MM IN SIZE. LENS WAS FOLDED NOT FAR IN ADVANCE, REALLY DONE JUST BEFORE IMPLANTATION. THE IOL WAS REMOVED FROM THE EYE WITHOUT COMPLICATIONS AND THE BACKUP LENS WAS IMPLANTED. OUTCOMES WERE EXPECTED TO BE GOOD, NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS WAS CUT IN SMALL PIECES AND TAKEN OUT DURING THE SAME SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19654864 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT SUFFERED CHAINING (WHICH FELT LIKE A SENSATION OF A CONTACT LENS COMING OUT OF THE EYE), BLURRY/FOGGY VISION DISRUPTING ALL ACTIVITIES (NEAR/FAR/IN-BETWEEN). IT APPEARED AS THOUGH THE LENS WAS GROWING INSIDE THE EYE. THE PATIENT'S VISION WAS GREAT UP CLOSE AND HAD GOTTEN WORSE FOLLOWING THE IMPLANT. THE PATIENT HAD NO TROUBLE SEWING OR CROCHETING BEFORE THE IMPLANTATION, BUT AFTERWARD, NEEDED GLASSES TO CARRY ON WITH EVERYDAY ACTIVITIES. THE INTERMEDIATE. DISTANCE AND FAR VISION WAS NOT SHARP. THE IMPLANTED LENS DID NOT CORRECT THE DULL APPEARANCE. PATIENT WAS NOT SATISFIED WITH THE RESULTS. THE DOCTOR CONCLUDED FROM THE MEDICAL PROGNOSIS THAT THE LENS WAS IN PLACE AND ADVISED WAITING 6-8 MONTHS TO SEE IF SYMPTOMS IMPROVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 17069653 ↗
• InjuryMay 29, 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 VISION WAS FUZZY AND BLURRY AND WAS UNABLE TO FOCUS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND WAS REPLACED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 17016763 ↗
• InjuryMar 28, 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 LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE REASON FOR THE EXPLANT WAS BLURRY VISION AND UNHAPPY WITH VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT REPORTED THAT THE VISION WAS NOT CRISP OR SHARP, AND HAD HALOS. THERE WAS NO HARM TO THE PATIENT AND THE SYMPTOMS HAVE RESOLVED. THE PROGNOSIS WAS EXCELLENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16627794 ↗
• InjuryMar 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BUSINESS MANAGER REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD MONOCULAR DIPLOPIA. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: Visual Disturbances

  MAUDE report 16597911 ↗
• MalfunctionJan 8, 2023Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING SURGERY THE NICK WAS NOTED IN THE MIDDLE OF THE LENS AND HAD TO BE CUT OUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT LENS WAS EXPLANTED SAME DAY AND CHANGED WITH THE REPLACEMENT LENS, THERE WAS NO PATIENT HARM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16119392 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED PANOPTIC LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED AND STATED PATIENT'S VISION WAS RESOLVED WITH 20/30 MONOVISION LENS. SURGEON'S PROGNOSIS WAS GOOD.

  Patient problems: Insufficient Information

  MAUDE report 15930467 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS UNKNOWN. ADDITIONAL INFORMATION AHS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Insufficient Information

  MAUDE report 13926397 ↗
• MalfunctionMar 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A DOT WAS OBSERVED ON THE LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768527 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT¿S VISUAL ACUITY WAS NOT GOOD EVEN WITH CORRECTION AND THE PATIENT WAS DISSATISFIED. ACCORDING TO PHYSICIAN, THE LENS SAT WELL AND CENTERED IN THE EYE. BEFORE THE SECOND SURGERY, THE BIOMETRICS WERE REPEATED AND DEVIATIONS WERE FOUND FROM THE ORIGINAL, FIRST BIOMETRICS. THE PHYSICIAN DOES NOT BELIEVE THAT THE IOL WAS THE CAUSE. THE LENS WAS EXCHANGED FOR MONOFOCAL IOL IN A SECONDARY PROCEDURE AND IS SATISFIED. THE EXPLANTED IOL WAS DISCARDED AND IS NOT AVAILABLE. THE PHYSICIAN WAS UNWILLING TO PROVIDE FURTHER INFORMATION.

  Patient problems: Visual Impairment

  MAUDE report 12228124 ↗
• InjuryJul 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED AN EXPLANTED INTRAOCULAR LENS WITH A PATIENT REASON FOR EXPLANT OF, VISION COMPLAINT AND A CLINICAL REASON FOR EXPLANT OF WRONG POWER. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 12197460 ↗
• InjuryJun 1, 2021Crack; Crack

  ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT IOL WAS EXCHANGED FOR THE SAME MODEL WITH A DIFFERENCE OF 2.0 DIOPTER OF POWER FOUR DAYS FOLLOWING THE INITIAL IOL IMPLANTATION PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11915913 ↗
• MalfunctionApr 13, 2021Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANTATION, A SCRATCHED LENS WAS FOUND. THE IOL WAS REPLACED IN THE SAME PROCEDURE WITH NO REPORTED HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11658133 ↗
• InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE PATIENT WAS NOT ABLE TO TOLERATE THE VISION. THE LENS WAS REMOVED AND REPLACED IN A SECONDARY SURGERY WITH ANOTHER POWER OF LENS. THE SURGEON STATED IT WAS AN INCORRECT IOL POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 11467061 ↗