AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380652357746), received between Aug 4, 2021 and Aug 19, 2026 — classified as 18 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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. 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 30 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  A health care professional reported that following intraocular lens (IOL) implantation, the patient's vision was not enough. Consequently, the lens was explanted and replaced during a secondary procedure with a third-party lens.

  Patient problems: Blurred Vision

  MAUDE report 50322265 ↗
• MalfunctionJul 17, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25854329 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY EXCHANGE WAS PERFORMED WITH A UNSPECIFIED REPLACEMENT LENS DUE TO PATIENT INTOLERANCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 25112212 ↗
• InjuryMay 2, 2025Adverse 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 DISCOMFORT. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 35 MONTH 12 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PATIENT ONLY EXPERIENCED DISCOMFORT AND NO VISION.

  Patient problems: Visual Impairment

  MAUDE report 21952079 ↗
• MalfunctionFeb 7, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE VISION IN THE RIGHT EYE (WHICH HAS HAD A YAG CAPSULOTOMY) HAS IMPROVED TO 0.0 LOGMAR UNAIDED FOR DISTANCE AND N5 UNAIDED FOR NEAR FOLLOWING A LASIK ENHANCEMENT PROCEDURE IN JANUARY. AS A RESULT, THE SURGEON RELUCTANT TO EXPLANT THE LENS FROM THE LEFT EYE (WHICH HAS NOT YET HAD A YAG CAPSULOTOMY). THE GLISTENING LOOK SYMMETRICAL AND NOW THAT THE REFRACTION HAS BEEN OPTIMIZED IN THE RIGHT EYE THE PATIENT IS HAPPY WITH THE VISION IN THAT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21332072 ↗
• InjuryFeb 3, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE VISION IN THE RIGHT EYE (WHICH HAS HAD A YAG CAPSULOTOMY) HAS IMPROVED TO 0.0 LOGMAR UNAIDED FOR DISTANCE AND N5 UNAIDED FOR NEAR FOLLOWING A LASIK ENHANCEMENT PROCEDURE IN JANUARY. AS A RESULT, THE SURGEON RELUCTANT TO EXPLANT THE LENS FROM THE LEFT EYE (WHICH HAS NOT YET HAD A YAG CAPSULOTOMY). THE GLISTENING LOOK SYMMETRICAL AND NOW THAT THE REFRACTION HAS BEEN OPTIMIZED IN THE RIGHT EYE THE PATIENT IS HAPPY WITH THE VISION IN THAT EYE.

  Patient problems: Blurred Vision

  MAUDE report 21291601 ↗
• MalfunctionJan 16, 2025Failure to Eject; Failure to Eject

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE IMPLANT WAS STUCK IN THE CARTRIDGE AND COULD NOT BE INJECTED. THE SURGERY WAS COMPLETED USING A BACKUP COMPANY LENS OF THE SAME MODEL AND DIOPTER. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167975 ↗
• MalfunctionDec 27, 2024Defective Component; Defective Component

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BROKEN DURING IOL INSERTION STAGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 21025653 ↗
• InjuryMay 21, 2024Adverse 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, TWO DAYS AFTER SURGERY THE PATIENT EXPERIENCED BLURRY VISION. TWO WEEK LATER THE DOCTOR ADVISED A LASER PROCEDURE TO IMPROVE THE VISION BUT THAT DID NOT IMPROVED. THE VISION WAS NOT IMPROVED. THE PATIENT NO LONGER WANTS TO RETURN TO DOCTOR. THE PATIENT WENT TO ANOTHER DOCTOR WHO TOLD HER THAT THE LENSES SHE HAD BEEN FITTED WITH WERE NOT SUITABLE AND SAID THAT SHE SHOULD HAVE BEEN FITTED WITH A MONOFOCAL LENS.

  Patient problems: Blurred Vision

  MAUDE report 19359155 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SYMPTOMS WERE STILL ONGOING AND PATIENT SAID THE LIGHTS OF CARS WERE GLARING HAVE SORT OF RAYS AROUND THEM. PATIENT GET TIRED AT HOME DURING CUTTING AND READING. THE EYES WERE PINCHING ALL DAY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Eye Pain; Photophobia; Visual Disturbances

  MAUDE report 18844897 ↗
• MalfunctionNov 24, 2023Defective Component; Defective Component

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC CAME LOOSE OR BROKE INSIDE THE PATIENT'S EYE. THE LENS WAS THEN REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. THIS RESULTED IN CORNEAL EDEMA. THERE WAS PATIENT HARM.

  Patient problems: Corneal Edema

  MAUDE report 18204707 ↗
• MalfunctionJun 27, 2023Particulates; Particulates

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, IT WAS NOTED THAT THERE WAS SOMETHING STRANGE INSIDE THE LENS ITSELF THAT COINCIDED WITH THE PATIENT'S VISUAL AXIS AND THAT THE SAME WOULD NOT ALLOW THE PATIENT TO SEE CORRECTLY. LENS WAS EXPLANTED AND IMPLANTED WITH ANOTHER LENS OF THE SAME TYPE AND SAME DIOPTER THAT HE HAD FOR THE OTHER EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema

  MAUDE report 17207713 ↗
• InjuryMay 2, 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 INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT HAD VISION PROBLEMS. THE PATIENT¿S LEFT EYE IS THE WORST AND DON'T KNOW IF ITS THE SURGEON OR THE LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT HAD A SECOND OPINION FOR FEAR THAT, WAS GOING TO GO BLIND BUT THE PHYSICIAN HAS ASSURED ME THAT PATIENT SIGHT SHOULD NOT DETERIORATE MUCH MORE THAN IT HAS AND HE SEES NO SIGNS OF BLINDNESS. THE PATIENT SAYS BROCHURE IS NOTHING LIKE THE RESULTS. THE PATIENT DOESN¿T HAS DISTANCE VISION AS WELL AS WAS SUGGESTED, AND HAVE INFERIOR MID RANGE AND CLOSE UP VISON. THE NIGHT VISON IS FAR WORSE THAN EXPECTED. THE PATIENT HAS HALO AND STARRING AROUND ALL THE LIGHTS ALONG WITH VISON NOT ANY BETTER THAN IT WAS, NIGHT DRIVING IS VERY DIFFICULT AND I CAN BARELY DRIVE ANYWHERE. THE PATIENT SAYS, HAVE LOST MY DESIRE TO DO SOME OF THE THINGS PATIENT USED TO ENJOY. SHOPPING AND TRYING TO SEE IS WORSE THAN IT WAS BEFORE SURGERY. WATCHING GRANDSON PLAY BASEBALL THROUGH A FENCE OR BASKETBALL IN AN GYM GIVES TROUBLE BECAUSE IT¿S A DEPTH PROBLEM THAT IF HARD TO COMPREHEND. THE EYE SURGEON SAID HE COULD TRY TO REMOVE THEM BUT COULD N

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16855229 ↗
• MalfunctionMar 29, 2023Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION AHS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16635153 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXCHANGED FOR AN UNKNOWN REASON. THERE WAS NO PATIENT HARM, AND PATIENTS ISSUES WERE RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 16241317 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD ONGOING PROBLEMS WITH GLARE, INCLUDING GLARE WHEN INSIDE WITH BRIGHT LIGHTS. THE PATIENT WORE SUNGLASSES OUTSIDE WITH POLARIZED LENSES, TRIED WEARING THESE SUNGLASSES INSIDE TOO (THEATER, AT BRIDGE CLUB), BUT THEN IT'S TOO DARK. THIS HAS NEGATIVELY IMPACTED CONSUMERS QUALITY OF LIFE. 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: Visual Disturbances

  MAUDE report 16215449 ↗
• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD ONGOING PROBLEMS WITH GLARE, INCLUDING GLARE WHEN INSIDE WITH BRIGHT LIGHTS. THE PATIENT WORE SUNGLASSES OUTSIDE WITH POLARIZED LENSES, TRIED WEARING THESE SUNGLASSES INSIDE TOO (THEATER, AT BRIDGE CLUB), BUT THEN IT'S TOO DARK. THIS HAS NEGATIVELY IMPACTED CONSUMERS QUALITY OF LIFE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 16215445 ↗
• MalfunctionJan 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL TORE AT THE TIME OF IMPLANTATION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THERE WAS PATIENT CONTACT NOTED AND THE SURGERY WAS COMPLETED BY REPLACING THE IOL WITH ANOTHER IOL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156768 ↗
• InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED CONSTANT WAVY MOTION, MOTION SICKNESS AND DIZZINESS. THE CLINICAL REASON WAS VERTIGO AND HEADACHE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOR MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT FELT SICK TO HER STOMACH THE WHOLE TIME AND SHE COULDN'T FUNCTION AT WORK OR AT HOME WITHIN A DAYS AFTER SURGERY. SHE FELT LIKE WAS ON THE OCEAN THE WHOLE TIME WITH WAVES. THE PATIENT WAS FEELING FANTASTIC WITH THE NEW MONOFOCAL LENS. THERE WAS NO PATIENT HARM AND THE PATIENT ISSUE WAS RESOLVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Headache; Vertigo

  MAUDE report 16066082 ↗
• InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MACULAR EDEMA OCCURS THOUGH PATIENT USES SUNGLASSES IN THE SUMMER MONTHS. THE PATIENT COMPLAINTS OF BURNING AND STINGING. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT PATIENT EXPERIENCED HYPERSENSITIVITY TO LIGHT AND THERE IS A GREAT PAIN BEHIND THE EYE AND THE VISION BECOME ICY. THE NSAIDS (NONSTEROIDAL ANTI-INFLAMMATORY DRUG) WAS USED FOR THE TREATMENT, THE EDEMA DISAPPEARED AND THEN CAME BACK AGAIN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain; Macular Edema; Visual Disturbances

  MAUDE report 15915255 ↗
• MalfunctionJul 12, 2022Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE LENS IMPLANTATION A DEFECT BETWEEN OPTICS AND HAPTICS AS A FRACTURE WAS NOTICED BY THE PHYSICIAN. IT WAS DECIDED THAT THE LENS BE CUT OUT AND REMOVED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A BACK UP LENS OF THE SAME DIOPTER AND MODEL. THERE WAS NO HARM TO THE PATIENT, AND NO COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 14988508 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT LEFT EYE NEVER CLEARED AND IT STEADILY WORSENING. LASER WAS PERFORMED TWICE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING IN SURGEONS OPINION HER SYMPTOMS APPEARED MOSTLY SECONDARY TO CAPSULAR OPACITY AND MOBILE CAPSULAR REMNANT.

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

  MAUDE report 14776260 ↗
• InjuryApr 1, 2022Component Missing; Component Missing

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS HAD A UNSPECIFIED DEFECT HENCE IT WAS IMPLANTED AND REMOVED IN THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS IMPLANTED BUT IT HAD ONLY ONE HAPTIC. PATIENT LEFT AND WAS REFERRED TO ANOTHER SURGEON TO GET THE LENS REMOVED AND EXCHANGED THE FOLLOWING WEEK.

  Patient problems: Insufficient Information

  MAUDE report 13975008 ↗
• InjuryFeb 10, 2022Scratched Material; Scratched Material

  A HEALTH PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR (IOL) IMPLANT SURGERY, IT WAS REALIZED THAT THE LENS HAD A SCRATCH IN THE ENTIRE HALF AT THE MOMENT OF FITTING IT IN THE EYE. THE DOCTOR REMOVED THE LENS WITH SCISSORS AND CLAMP AND IT COME OUT SHATTERED. ANOTHER LENS WITH THE SAME POWER WAS REQUESTED BUT THERE WAS NO BACKUP OF THIS AND IT WAS REPORTED FOR THAT THEY WENT TO BRING IT. THE PATIENT WAS LEFT IN RECOVERY WITH VISCOELASTIC DURING THE LENS ARRIVAL. ONCE THE LENS ARRIVED, THE PATIENT WAS TAKEN BACK TO THE SURGERY ROOMS TO IMPLANT THE LENS UNDER VISCOELASTIC AND IT WAS WASHED. THE LENS WAS IMPLANTED IN THE LEFT EYE, A PARACENTESIS WAS SEALED AND ANTIBIOTICS WERE LEFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506972 ↗
• MalfunctionFeb 7, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A SCRATCH WAS FOUND ON THE LENS OPTIC AFTER IOL LOADING INTO THE EYE. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED. A QUESTIONNAIRE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470242 ↗