AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652357784), received between Mar 29, 2021 and May 5, 2026 — classified as 13 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (7 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Failure to Deliver

  A PHARMACIST REPORTED THAT THE INTRAOCULAR LENS COULD NOT BE IMPLANTED. IT WAS REPORTED THAT, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080136 ↗
• MalfunctionOct 22, 2025Material Discolored; Material Discolored

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SEVEN DAYS POSTOPERATIVELY, THE PATIENT COMPLAINED OF DECREASED VISION. AFTER A CONSULTATION, THE DOCTOR OBSERVED AN IMAGE IN THE ANTERIOR PHASE OF THE INTRAOCULAR LENS THAT APPEARED TO BE SOME SPOTS IN ITS OPTICAL ZONE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DIAGNOSIS WAS OPACITY IN THE ANTERIOR REGION OF THE IOL. IOL EXCHANGE WILL BE PERFORMED.

  Patient problems: Blurred Vision

  MAUDE report 23358170 ↗
• MalfunctionSep 9, 2025Failure to Deliver; Failure to Deliver

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STIFF END WAS NOT COMING RIGHT OUT OF THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 23005522 ↗
• InjuryOct 8, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE AN HAPTIC WAS SEPARATED FROM THE LENS WHEN OPENED AND IT WAS DECIDED TO IMPLANT IT AS THERE WAS NO RESERVE. ON CHECKING THE NEXT DAY, IT WAS OBSERVED THAT THE LENS WAS NOT STABILIZED IN THE CAPSULAR BAG.THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL TWO MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20394485 ↗
• MalfunctionJun 26, 2024Scratched Material; Failure to Eject; Scratched Material; Failure to Eject

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS GOT STUCK IN THE CARTRIDGE AND SCRATCHED THE OPTICAL ZONE OF THE LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19612928 ↗
• MalfunctionApr 10, 2024Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE THE PRODUCT WAS BEING INSERTED, LENS HAPTIC BROKEN. THE BROKEN PART COULD NOT BE FOUND. LENS WAS EXPLANTED AT INITIAL PROCEDURE. THE LENS WAS REPLACED WITH UNSPECIFIED LENS, AND POST-OPERATION IRREGULAR ASTIGMATISM OCCURRED.

  Patient problems: Visual Impairment

  MAUDE report 19078253 ↗
• InjuryFeb 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DUE TO LIGHT REFLECTIONS, SHE COULDN'T SEE ANYTHING. WHEN SHE MENTIONED THE SITUATION TO PHYSICIAN, SHE WAS TOLD THERE'S NOTHING WRONG, EVERYTHING WAS NORMAL. ABOUT 20-30 DAYS LATER, IT WAS SAID THAT THE LENS WAS SURROUNDED BY THE EYE MEMBRANE AND WAS CLEANED. AFTER ONE MONTH, SHE PERSISTENTLY MENTIONED THAT SHE COULDN'T SEE, AND THE DISCOMFORT PERSISTED. IT WAS STATED THAT THERE WAS A DISPLACEMENT, AND THE LENS WAS PUT BACK IN PLACE, BUT HER VISION STARTED DETERIORATING EVERY DAY. SHE HAS BEEN MENTALLY EXHAUSTED. WHEN SHE WENT FOR A CHECK-UP WITH A BLURRY VISION AND A FEELING OF HAVING WATER INSIDE, SHE WAS TOLD EVERYTHING WAS NORMAL; HOWEVER, THERE WAS NO IMPROVEMENT IN HER VISION, AND THE PROBLEM CONTINUED TO WORSEN. IN THIRD MONTH, SHE WENT TO ANOTHER DOCTOR. IT WAS STATED THAT THERE WAS A DEVIATION IN THE PRESCRIPTION, AND THE WRONG PRESCRIPTION COMPANY LENS WAS IMPLANTED. SHE COULDN'T DETERMINE WHETHER IT'S COMPANY OR THE DOCTOR WHO WAS AT FAULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE CONSUMER ADVISED THAT THERE HAD BEEN A PRESCRIPTION ERROR WHILE TRYING TO CORRECT

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

  MAUDE report 18638994 ↗
• MalfunctionDec 29, 2023Defective Device; Defective Device

  A PHARMACIST REPORTED A DEFECTIVE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18417475 ↗
• InjuryDec 22, 2023Break; Malposition of Device; Break; Malposition of Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS HAPTIC WAS BROKEN IN THE CAPSULAR BAG AND THE LENS WAS DECENTERED DUE TO WHICH THE PATIENT EXPERIENCED GLARE AND HALOS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT AFTER THE LENS EXCHANGE THE PATIENT'S VISION WAS IMPROVED AND PATIENT IS NOT EXPERIENCING ANY GLARE OR HALOS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18382588 ↗
• InjuryNov 16, 2023Adverse 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 EXPERIENCED BLURRY VISION. CLINICAL REASON BEING REFRACTIVE SURPRISE. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT HARM. PATIENT HAD A POSTOPERATIVE REFRACTIVE SURPRISE AFTER SURGERY DESPITE GOOD PREOPERATIVE BIOMETRY UTILIZING ARGOS DUE TO COMPANY LENS.

  Patient problems: Blurred Vision

  MAUDE report 18149132 ↗
• MalfunctionOct 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS TORN WHEN PLACED INSIDE THE EYE USING THE CARTRIDGE, BUT THERE IS NO PERMANENT DAMAGE TO THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17913229 ↗
• MalfunctionJul 24, 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 PATIENT WAS VISUALLY DISTURBED BY THE MATERIAL CHANGES. THE LENS HAD GLISTENING'S. AS PER THE PHYSICIANS SO FAR NO FURTHER TREATMENTS HAVE TAKEN PLACE.

  Patient problems: Visual Disturbances

  MAUDE report 17378268 ↗
• 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 IN THE LEFT EYE, THERE WAS GLARE (SIMILAR TO THE SENSATION OF A CONTACT LENS COMING OUT OF THE EYE), HALOS WITH LOTS OF CIRCLES AROUND LIGHTS MAKING IT DIFFICULT TO DRIVE AT NIGHT, FLICKERING (NOT SO OFTEN), BLURRY/HAZY VISION DISRUPTING ALL NEAR/FAR/INTERMEDIATE VISION, PRIMARILY INTERMEDIATE AND FAR, BUT OCCURRED UP CLOSE AS WELL. PERIPHERAL VISION WAS ALSO COMPROMISED IN THE CONSUMER. THE PHYSICAL ACTIVITIES WERE ALSO HINDERED. IT DAMAGED THE CUSTOMER MENTALLY AS WELL; REASONING WAS VERY SLOW COMPARED TO WHAT IT WAS. THE CUSTOMER'S QUALITY OF LIFE SIGNIFICANTLY DECLINED DUE TO INABILITY TO DRIVE, WEAK REFLEXES, AND UNCERTAINTY ABOUT THE DISTANCE, AS WELL AS WORK INSECURITY. THE DOCTOR CONCLUDED FROM THE MEDICAL PROGNOSIS THAT THE LENS WAS IN PLACE AND WITH TIME IT COULD IMPROVE AND THAT THERE WOULD BE NO MORE SHARPNESS.

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

  MAUDE report 17069657 ↗
• MalfunctionMay 23, 2023Break; Break

  A OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE FAULTY DURING THE IMPLANTATION OF THE PATIENT AND COULD NOT BE USED. THIS LENS SHOULD BE REPLACED WITH A NEW LENS. THERE WAS NO ADDITIONAL INTERVENTION AND NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, AFTER THE IOL WAS IMPLANTED IN THE PATIENT'S EYE, THE OPTIC-HAPTIC JUNCTION WAS FOUND TO BE BROKEN, AND THE LENS WAS REMOVED AND A NEW ONE WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982633 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED THAT AFTER BILATERAL IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD REDUCED VISION. YAG LASER CAPSULOTOMY WAS PERFORMED. THE PATIENT WAS HAPPY WITH THE RIGHT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 16830491 ↗
• InjuryApr 26, 2023Break; Break

  A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT KEPT COMPLAINING ABOUT THE NIGHT VISION WHICH IS SEEN THE OBJECT APPEAR TO BE BROKEN AFTER SURGERY. THE SURGEON CHECKED THE PATIENT CONDITION AND FOUND THAT BROKEN PART AT THE EDGE OF LENS OPTIC. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 16814787 ↗
• MalfunctionApr 25, 2023Defective Device; Defective Device

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION A DEFECT WAS DETECTED IN THE OPTIC OF THE LENS WHICH WAS VISIBLE UNDER AN OPERATING MICROSCOPE. IT WAS SUBSEQUENTLY CUT NEXT TO THE DAMAGED PART AND PULLED OUT OF THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED BY USING ANOTHER LENS WITH THE SAME POWER. THE PATIENT FEELS WELL POSTOPERATIVELY, WITHOUT PROBLEMS, AND THE VISION WITH THE NEW REPLACEMENT LENS IS SATISFACTORY.

  Patient problems: Insufficient Information

  MAUDE report 16806297 ↗
• MalfunctionApr 10, 2023Defective Device; Defective Device

  ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS DID NOT PROGRESS IN THE INJECTOR SO THE SURGEON DECIDED TO CHANGE THE IMPLANT. THE LENS WAS NOT IMPLANTED SO THERE WAS NO REQUIREMENT OF LENS EXPLANT DURING INITIAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16707035 ↗
• InjuryMar 21, 2023Break; Break

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONE OF THE HAPTICS WAS FOUND BROKEN ONCE THE IOL WAS PLACED. THE IMPLANTATION AND LOADING INTO THE CARTRIDGE WENT SMOOTHLY. THE SURGEON HAS TO EXPLANT THIS IOL AND THE PATIENT WAS LEFT APHAKIC. THE NEW IOL WAS IMPLANTED IN SECONDARY PROCEDURE. NO CONSEQUENCE FOR THE PATIENT VISUAL ACUITY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, NO CONSEQUENCES FOR THE PATIENT, JUST AN ENLARGEMENT OF THE INCISION (INITIALLY 2.2MM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16580579 ↗
• InjuryMar 17, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT, FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR REFRACTIVE RESULT OF +1.0D AT 10 DAYS POST-OP. THERE HAVE BEEN TWO SCRATCHES NOTICED ON THE BOTTOM OF THE 2ND DIFFRACTIVE CIRCLE OF THE IMPLANT, WHICH WERE NOT SEEN DURING IMPLANTATION. ADDITIONAL INFORMATION RECEIVED AND STATED THAT REMOVED THE IMPLANT FROM THE PATIENT CONCERNED FOR THE SCRATCHES FOUND.

  Patient problems: Visual Impairment

  MAUDE report 16565134 ↗
• MalfunctionFeb 27, 2023Scratched Material; Scratched Material

  THIS IS A DUPLICATE OF MANUFACTURER REPORT NUMBER 1119421-2023-00480. NO ADDITIONAL REPORTS WILL BE FILED ON THIS REPORT NUMBER. ANY ADDITIONAL INFORMATION THAT IS RECEIVED WILL BE REPORTED ON MANUFACTURER REPORT NUMBER 1119421-2023-00480.

  Patient problems: Visual Impairment

  MAUDE report 16441927 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE RESULT IS NOT WHAT WAS EXPECTED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, STATING SHE EXPERIENCED IRREGULAR VISION IMMEDIATELY AFTER WAKING UP AFTER THE OPERATION. SHE EXPERIENCED DOUBLE VISION AND ONLY VISION IN SEPIA, NO GREEN OR OTHER COLORS. THE TREES AND GRASS ON THE OTHER SIDE OF THE ROAD WERE RUSHING TOWARDS HER FACE AND THEN, AT THE LAST MINUTE, VEERING OFF AT 45 DEGREES AND GOING PAST HER LEFT EAR. THE LANDSCAPE BECAME LIKE A WASHING MACHINE SWIRLING AROUND HER. SHE DOES NOT HAVE CLEAR, FOCUSED VISION OUT OF HER EYE AT ANY RANGE¿NEAR, MIDDLE, OR FAR. EVERYTHING WAS BLURRY. SHE CANNOT READ ON HER PHONE OR LAPTOP, AND THE TV WAS OUT OF FOCUS AS EVERYTHING WAS IN THE DISTANCE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 16262884 ↗
• MalfunctionJan 17, 2023Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, 3 O'CLOCK OPTIC AS IT WAS GOING INTO THE EYE, RADIAL SCRATCH WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16183271 ↗
• InjuryDec 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS IMPLANT PROCEDURE, IOL FOUND TO HAVE SPOT IN THE CENTER OF THE OPTIC. IOL REMAINED IMPLANTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE.

  Patient problems: Blurred Vision

  MAUDE report 15903188 ↗
• MalfunctionAug 17, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE FOREIGN BODY WAS NOTICED ON THE OPTIC OF THE LENS, SURGEON TRIED TO REMOVE IT WITH ASPIRATION BUT IT WAS UNABLE TO BE REMOVED. SURGEON CONFIRMED THAT IT ISN¿T A SCRATCH, LOOKED LIKE A THREAD. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15242461 ↗