AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652357739), received between Mar 5, 2021 and May 15, 2026 — classified as 17 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Defective Device” (3 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Failure to Deliver

  A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT WAS STUCK IN THE CARTRIDGE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184281 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION IN THE RIGHT EYE. UPON EXAMINATION, THE OPHTHALMOLOGIST FOUND THAT THE RETINA WAS NORMAL. HOWEVER, IOL EXHIBITED SIGNS OF GLISTENING.

  Patient problems: Blurred Vision

  MAUDE report 23597919 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED CONTINUED DISCOMFORT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.

  Patient problems: Visual Impairment

  MAUDE report 21941469 ↗
• InjurySep 20, 2024Adverse 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 BLURRED VISION FROM TWO YEARS CONSISTENTLY SINCE THE SURGERY. THE PATIENT WAS REFERRED FOR LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) AND DID NOT IMPROVE, HAS HAD YAG (YTTRIUM ALUMINUM GARNETT) AND NO IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20267064 ↗
• InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND GLARE WHEN DRIVING AT NIGHT WAS VERY DIFFICULT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19744079 ↗
• MalfunctionJun 26, 2024Defective Device; Defective Device

  A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19612596 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND UNEXPECTED REFRACTION. ADDITIONAL INFORMATION RECEIVED THAT THE LENS WAS EXPLANTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 19483397 ↗
• MalfunctionFeb 8, 2024Defective Device; Defective Device

  A HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18666458 ↗
• InjuryOct 17, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC BROKE OFF AND STUCK TO THE INJECTOR PLUNGER. ON POST-OPERATIVE INSPECTION THE IMPLANT DECENTERED. HENCE A SECONDARY PROCEDURE HAS BEEN PLANNED FOR EXPLANATION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS HAS BEEN EXPLANTED IN A SECONDARY PROCEDURE IN POST OPERATIVE INSPECTION AND REPLACED WITH ANOTHER LENS OF SAME MODEL.

  Patient problems: Insufficient Information

  MAUDE report 17947894 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER BILATERAL IMPLANTATION OF INTRAOCULAR LENS (IOL), EXPERIENCED HAD VISION PROBLEMS. THE CONSUMER HAD NO DISTANCE VISION, HAD INFERIOR MID RANGE AND CLOSE UP VISON. THE NIGHT VISON WAS FAR WORSE THAN EXPECTED. THE CONSUMER ALSO HAD HALOS AND STARRING AROUND LIGHTS, THE NIGHT DRIVING WAS VERY DIFFICULT AND CAN BARELY DRIVE ANYWHERE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16830488 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S VISION WAS VERY CLOUDY, GLARE, HALOS AND TROUBLE DRIVING AT NIGHT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONALLY PARS PLANA VITRECTOMY WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15977242 ↗
• MalfunctionNov 7, 2022Failure to Advance; Failure to Advance

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WOULD NOT DEPLOY. THERE WAS PATIENT CONTACT WITH THE DEVICE. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 15742011 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION THE PATIENT EXPERIENCED DISTANCE VISION, FUZZY/HAZY, TWITCHING/BLURRED AND FAILED FREQUENT LUBRICATION. ADDITIONAL INFORMATION WAS PROVIDED STATING PATIENT USED THE OTC(OVER THE COUNTER) ARTIFICIAL TEARS AND 2 DIFFERENT RX EYE DROPS TO HELP LUBRICATE THE EYE WITHOUT SUCCESS/PATIENT WAS USING ARTIFICIAL TEARS.

  Patient problems: Blurred Vision

  MAUDE report 15526916 ↗
• InjurySep 28, 2022Adverse 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 EXPERIENCED GLARE AND BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER 9 MONTHS OF INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS REDUCED BEST CORRECTED VISUAL ACUITY (BCVA) WITH AN ONGOING COMPLAINT OF GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 15500754 ↗
• MalfunctionSep 19, 2022Crack; Crack

  A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL OPTIC FOUND TO HAVE A CRACK UPON INSPECTING ON MICROSCOPE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS PATIENT CONTACT BUT NO PATIENT HARM. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15444562 ↗
• InjuryJun 3, 2022Adverse 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, PATIENT EXPERIENCED POOR VISION. THE CLINICAL REASON WAS QUALITATIVE POOR VISION. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT OTHER COMPANY REPLACEMENT LENS WAS USED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Impairment

  MAUDE report 14593402 ↗
• InjuryMar 22, 2022Adverse 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 PATIENT EXPERIENCED GHOSTED, DOUBLE VISION AND BLURRY IN ALL FIELDS. ADDITIONAL INFORMATION WAS PROVIDED THAT SHE STARTED TO EXPERIENCE A THIN LINE OF PERIPHERAL VISION WITH SHIMMERING, FLICKERING AND GLARE FROM THE BOTTOM OF THE LENS WITH BLURRY AND GHOSTED VISION, THIS IS HAPPENING 24/7 SINCE THE SURGERY, SHE IS HAVING DIFFICULTY WORKING AS A DENTAL HYGIENIST AND NEED FINE DETAIL AND HAVING DIFFICULTY DRIVING AND HAD DONE MINIMAL SINCE SURGERY DATE, SHE CANNOT DRIVE AT NIGHT DUE TO THE SHIMMERING, HALOS AND GLARE THAT RADIATES INTO THE FIELD OF VISION. SHE IS HAVING DAILY HEADACHES DUE TO THE DISTORTION IN THE VISION AND STRAIN. PATIENT SAID THAT SHE IS VERY OUTDOORSY AND HAVE NOT BEEN ABLE TO DO ANY SPORTS ETC. SINCE SURGERY. SHE CANNOT BE ABLE TO DO RECREATIONAL WALK DAILY DUE TO DISTORTION AND VISUAL PHENOMENA. PATIENT WAS DISAPPOINTED FROM THE OUTCOME OF THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFO AVAILABLE.

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

  MAUDE report 13854502 ↗
• MalfunctionFeb 3, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PRODUCT WAS RECEIVED DEFECTIVE. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 13439228 ↗
• InjuryDec 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13125400 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT CANNOT SEE FAR DISTANCES AT NIGHT OR DAY. THE LENS WAS EXCHANGED APPROXIMATELY 4 MONTHS LATER IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 13003946 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIRECTOR REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT CAN NOT SEE AT DISTANCE - NIGHT OR DAY AND THE LENS WAS EXCHANGED FOR A DIFFERENT LENS WITHIN 5 MONTHS AFTER INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS UNINTENDED MYOPIC. ADDITIONAL INFORMATION WAS RECEIVED STATING IN SURGEONS OPINION THE SURGERY WAS GOOD WITH REFRACTION AND THE PATIENT WAS NOT ABLE TO OBTAIN THE GOOD VISION. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12954203 ↗
• InjuryNov 24, 2021Adverse 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, THE PATIENT EXPERIENCED GLARE, CLOUDINESS, BLURRY VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 9 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT REPORTED INTOLERABLE HALOS AND GLARE, EVEN THOUGH PATIENT HAD A GOOD SNELLEN VISUAL ACUITY, STILL HER VISION WAS BLURRY AND SHE NEEDED GLASSES.

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

  MAUDE report 12867416 ↗
• MalfunctionOct 26, 2021Device Damaged by Another Device; Device Damaged by Another Device

  A PHARMACIST REPORTED DURING AN IOL IMPLANTATION PROCEDURE, THE LENS SUFFERED DEFORMATION FROM THE PRESSURE OF THE INJECTOR. THE INJECTOR BENT THE HAPTIC INSIDE THE EYE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696415 ↗
• InjuryOct 11, 2021Adverse 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 ASTIGMATISM WAS NOT CORRECTED, STILL HAVE SOME DIFFICULTY READING BOOKS AND CANNOT READ CAPTIONS ON THE TV OR ROAD SIGNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND REPORTED THAT THE CONSUMER HAD ISSUES WITH SEEING AT ALL DISTANCES AND ASTIGMATISM HAS NOT RESOLVED, LIMBAL RELAXING INCISIONS (LRI) INCISIONS THAT SURGEON MADE WERE FOR CORRECTING ASTIGMATISM.

  Patient problems: Blurred Vision

  MAUDE report 12606883 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF AN INTRAOCULAR LENS (IOL) A PATIENT EXPERIENCED TOXIC ANTERIOR SEGMENT SYNDROME (TASS). ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR THE PATIENT'S FELLOW EYE.

  Patient problems: Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 11423003 ↗