AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652414975), received between Mar 18, 2021 and Jan 21, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 21, 2025Adverse 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, PATIENT EXPERIENCED BLURRED DISTANCE VISION, CLOUDINESS, FLOATERS, AND LIGHT GLARE IMPACTING LIFE. PATIENT UNDERGONE LASIK SURGERY TO CORRECT DISTANCE VISION. AFTER SURGERY PATIENT INTERMEDIATE VISION IMPROVED DISTANCE VISION IS NOT IMPROVED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE DAY AFTER FIRST SURGERY ON (B)(6) 2022, NOTICED VISION WAS STILL BLURRY AND THERE WAS A WHITE FOG PATIENT STATED LIKE LOOKING THROUGH. IN ALL THERE WAS NO IMPROVEMENT TO VISION, WITH GLARE FROM LIGHTS, FOGGY AND BLURRY VISION. AFTER SECOND SURGERY ON (B)(6) 2022 VISION BECAME WORSE WITH CONTINUED WHITE FOG AREAS COMING AND GOING, GLARE FROM LIGHTS, A SINCE OF DISTORTION, BLURRINESS AND A FEELING EYES WERE STRAINING TO FOCUS. THE PATIENT STATED AFTER SURGERY VISION WAS WORSE THAN BEFORE SURGERY. THE PATIENT STATED HE HAS GONE FOR A 1 DAY, 1 WEEK, 3 MONTH AND 6 MONTH FOLLOW UPS, AND CONSTANTLY TOLD THEM OF PROBLEMS. THE PATIENT WAS GIVEN DIFFERENT EYE DROPS, WHICH DID NOT HELP, AND TOLD EVERYTHING WAS FINE. THE FOLLOW UPS WERE NOT DONE BY SURGEON WHO PERFORMED THE SURGERY BUT ANOTHER PHYSICIAN IN THE PRACTICE. ON (

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

  MAUDE report 21196543 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), A CUSTOMER COMPLAINED OF DRY EYES. THE CUSTOMER HAD TEAR DUCT PLUGS PLACED MULTIPLE TIMES AND UTILIZED THE PRESCRIBED EYE DROPS, BUT THE CONDITION DIDN'T GET ANY BETTER. AFTER APPLYING A PLACENTA PATCH AND AFTERWARDS A LASER TO REDUCE SCAR TISSUE, THE CONSUMER ONCE MORE EMPLOYED THE ADVISED EYE DROPS. EVEN PRESCRIPTION READERS, PRESCRIPTION DISTANCE LENSES, AND TRIFOCAL SPECTACLES WERE UTILIZED BY CONSUMER. ALL OF THESE WERE HELPFUL, BUT THEY DIDN'T SOLVE EVERY ISSUE. FOR EXAMPLE, SOME OF THE LETTERS WERE FADED AND OCCASIONALLY WEREN'T DARK ENOUGH TO BE SEEN ON THE PAGE. NOTHING IN A PICTURE WAS APPARENT TO THE CONSUMER WHEN LOOKED AT IT. LARGE LIGHTED CIRCLES AND LINES AROUND ALL LIGHTS WERE AMONG THE OTHER ISSUES THAT CONSUMER OBSERVED. THIS WAS MOSTLY AN ISSUE WHEN DRIVING THROUGHOUT THE DAY OR MORE SO AT NIGHT BECAUSE IT MADE IT DIFFICULT TO SEE WHEN OTHER CARS WERE AROUND. AS A RESULT, CONSUMER STOPPED DRIVING AT NIGHT. BECAUSE THE CONSUMER HAD DIFFICULTIES WITH DEPTH PERCEPTION, MOVING AROUND WAS PROBLEMATIC, GLARE WAS AN ISSUE, AND SWITCHING FROM LIGHT TO DARK WAS CHALLENGING. TO PERCEIVE AN OBJECT, THE CONSUMER HAS TO LOOK ST

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

  MAUDE report 17314319 ↗
• MalfunctionJul 27, 2022Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS SCRATCHED, HENCE THE LENS WAS REMOVED AND REPLACED WITH THE SAME MODEL TYPE OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116201 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 14594429 ↗
• InjuryMay 27, 2022Adverse 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 HAD EXPERIENCED POOR DISTANCE AND NEAR VISION. THE PATIENT COULD NOT TOLERATE THE LENS AND THE EYES WOULD STRAIN. HENCE THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND THE PATIENT ISSUES HAVE RESOLVED AFTER THE LENS EXCHANGE. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THE PROGNOSIS WAS GOOD. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 14522377 ↗
• InjuryJul 22, 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 PATIENT EXPERIENCED SEVERE GLARE, STARBURST, HALO AT NIGHT TIME AND DRIVING AT NIGHT BORDERS ON BEING DANGEROUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12210068 ↗
• InjuryMar 31, 2021Adverse 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) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED SEVERE GLARE AND HALOS. THE IOL WAS EXCHANGED FOR A DIFFERENT LENS MODEL APPROXIMATELY 2 MONTHS AFTER THE INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11595429 ↗
• InjuryMar 22, 2021Adverse 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 BLUR, HALOS AND DIFFICULT NIGHT DRIVING. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 11542187 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE EXPERIENCED SEVERE GLARE AND STARBURSTS TO THE DEGREE THAT HE NO LONGER FEELS SAFE DRIVING AT NIGHT. THE PATIENT REPORTED HE HAD PRIOR BILATERAL LASIK PROCEDURES. THE PATIENT HAS PROVIDED ADDITIONAL INFORMATION THAT HE BEGAN EXPERIENCING PROBLEMS IMMEDIATELY AFTER THE LENSES WERE INSERTED. CURRENTLY HE IS UNABLE TO DRIVE AT NIGHT AND DURING A NORMAL SUNNY DAY HE FEELS LIKE HIS EYES ARE PERMANENTLY DILATED. HE HAS TO WEAR SUNGLASSES ALL THE TIME WHEN OUTSIDE IF IT'S NOT OVERCAST. ADDITIONALLY, HE IS SEEING GHOST IMAGES AROUND OBJECTS IN HIS FIELD OF VIEW, MORE PRONOUNCED AT NIGHT. THE PATIENT HAS DISCUSSED THESE ISSUES WITH HIS SURGEON. HE DOES NOT BELIEVE THAT LENSES ARE AT FAULT HERE. THE PATIENT BELIEVES THAT CERTAINLY THE INTERACTION BETWEEN THE PRIOR LASIK AND THE LENSES ARE THE PROBLEM. EVEN WITH HIS PUPILS ALMOST COMPLETELY CLOSED HE IS UNCOMFORTABLE IN NORMAL DAYLIGHT. DRIVING IS UNCOMFORTABLE IN THE DAYTIME, AND UNSAFE AT NIGHT. HALOS, STARBURST AND GHOST IMAGES ARE THE PROBLEMS. HIS SURGEON HAS REFERRED HIM BACK TO HIS LASIK DOCTOR AND HE HAD AN APPOINTMENT WITH HER. HER FEEDBACK WAS

  Patient problems: Unspecified Eye / Vision Problem; Visual Disturbances; Visual Impairment

  MAUDE report 11514651 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT PROCEDURES, HE EXPERIENCED SEVERE GLARE AND STARBURSTS TO THE DEGREE THAT HE NO LONGER FEELS SAFE DRIVING AT NIGHT. THE PATIENT REPORTED HE HAD PRIOR BILATERAL LASIK PROCEDURES. THE PATIENT HAS PROVIDED ADDITIONAL INFORMATION THAT HE BEGAN EXPERIENCING PROBLEMS IMMEDIATELY AFTER THE LENSES WERE INSERTED. CURRENTLY HE IS UNABLE TO DRIVE AT NIGHT AND DURING A NORMAL SUNNY DAY HE FEELS LIKE HIS EYES ARE PERMANENTLY DILATED. HE HAS TO WEAR SUNGLASSES ALL THE TIME WHEN OUTSIDE IF IT'S NOT OVERCAST. ADDITIONALLY, HE IS SEEING GHOST IMAGES AROUND OBJECTS IN HIS FIELD OF VIEW, MORE PRONOUNCED AT NIGHT. THE PATIENT HAS DISCUSSED THESE ISSUES WITH HIS SURGEON. HE DOES NOT BELIEVE THAT LENSES ARE AT FAULT HERE. THE PATIENT BELIEVES THAT CERTAINLY THE INTERACTION BETWEEN THE PRIOR LASIK AND THE LENSES ARE THE PROBLEM. EVEN WITH HIS PUPILS ALMOST COMPLETELY CLOSED HE IS UNCOMFORTABLE IN NORMAL DAYLIGHT. DRIVING IS UNCOMFORTABLE IN THE DAYTIME, AND UNSAFE AT NIGHT. HALOS, STARBURST AND GHOST IMAGES ARE THE PROBLEMS. HIS SURGEON HAS REFERRED HIM BACK TO HIS LASIK DOCTOR AND HE HAD AN APPOINTMENT WITH HER. HER FEEDBACK WAS

  Patient problems: Unspecified Eye / Vision Problem; Visual Disturbances; Visual Impairment

  MAUDE report 11514446 ↗