AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652357715), received between May 20, 2021 and Jul 5, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2024Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED A SCRATCH ON THE LENS. THE PROCEDURE WAS COMPLETED.ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19679086 ↗
• MalfunctionMar 18, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THE LENS WAS HARDENED AND DID NOT UNFOLD UPON IMPLANTATION. SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL . ADDITIONAL INFORMATION WAS RECEIVED AND NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18920218 ↗
• MalfunctionMar 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  A SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INSERTING THE LENS SURGEON NOTED A SMALL TEAR IN THE EDGE OF THE OPTIC AND SHE KEPT THE LENS INSERTED AND WOULD DECIDE IN FUTURE IF AN IOL EXCHANGE IS NEEDED. ADDITIONAL INFORMATION HAS BEEN RECEIVED BY SURGEON STATING THAT NO PATIENT HARM, ISSUE IS NOT RESOLVED, PROGNOSIS IS FAIR AT THE TIME OF REPORTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825991 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) LENS IMPLANTATION SURGERY, ON (B)(6) 2023 AFTER GETTING DONE AT THE GYM, THE PATIENT NOTICED HER VISION WAS OFF. IT CONTINUED TO GET WORSE, AND SHE WAS DESCRIBING IT AS DOUBLE VISION. THE PATIENT STATED THAT WHEN SHE COVERED EACH EYE INDIVIDUALLY SHE COULD SEE NORMALLY, BUT WHEN SHE HAD BOTH EYES OPENED SHE SAW DOUBLE, THAT WORSENS IN CERTAIN GAZES SUCH AS DOWN AND UP AND TO THE RIGHT. THE PATIENT MENTIONED THAT SHE WAS SEEN IN THE EMERGENCY ROOM ON SAME DAY AND ALSO EVALUATED BY NEURO-OPHTHALMOLOGY. THE LENS WAS APPARENTLY IN POSITION AND THEY COULDN'T SEE A REASON FOR THE DIPLOPIA. THEY WILL BE DOING AN MAGNETIC RESONANCE IMAGING (MRI) OF HER HEAD AND ORBITS ON (B)(6) 2023 TO RULE OUT A POSSIBLE STROKE OR OTHER ETIOLOGY. HER FOLLOW-UP APPOINTMENT WITH HER NEURO-OPHTHALMOLOGIST WAS ON (B)(6) 2023. SHE HAS ALSO HAD A LOT OF BLOODWORK DONE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED FROM THE CONSUMER STATING THAT SHE HAS NOW HAD HEADACHES FOR TWO WEEKS. WALKING HAS BECOME VERY DIFFICULT BECAUSE IF BOTH EYES ARE OPEN, IT REALLY THROWS HER OFF. THE PATIENT CAN¿T DRIVE RIGHT NOW BECAUSE SHE DOESN¿T WANT TO DEPEND ON BAD VI

  Patient problems: Diplopia/Double Vision; Headache

  MAUDE report 18482460 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING THE IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT EXPERIENCED DYSPHOTOPSIAS AND INTOLERABLE HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 15527773 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DYSPHOTOPSIAS (STRUGGLING WITH VISION). THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 15527761 ↗
• InjuryAug 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS REMOVED FROM THE EYE DUE TO A PATIENT REASON OF BLURRED VISION AND A CLINICAL REASON OF WRONG POWER. LENS WAS REPLACED WITH ANOTHER LENS.

  Patient problems: Blurred Vision

  MAUDE report 15138682 ↗
• InjuryMay 25, 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 WAS NOT HOSPITALIZED FOR THE EVENT. THE PROGNOSIS WAS GOOD. PATIENT ISSUES HAVE RESOLVED AFTER THE LENS EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 14494742 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CLINICAL DIRECTOR REPORTED THAT FOLLOWING AN IOL IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY DISTANCE AND NEAR VISION DUE TO INCORRECT POWER. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL WITH 2D DIFFERENCE IN POWER, IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12393761 ↗
• MalfunctionMay 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THERE WAS A COATING OF THE LENS. THE LENS DID COME INTO CONTACT WITH THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 11855257 ↗