AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652357821), received between Feb 18, 2022 and Oct 5, 2024 — classified as 8 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  A SURGEON REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON OPENED THE PACKAGE AND FOUND A WHITE COLOURED LINE ON THE SURFACE OF THE LENS EXTENDING TO THE POSTERIOR SURFACE. TRIED TO SCRAP IT, BUT SOME AMOUNT OF WHITE MATERIAL CAME OUT. SO, PROCEDURE WAS ABANDONED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THE PATIENT WAS LEFT APHAKIC FOR ONE DAY. AS PATIENT WAS LEFT APHAKIC WHICH HAS ITS OWN COMPLICATIONS. THE PATIENT WAS IMPACTED WITH INDUCED ASTIGMATISM OF 0.5D AS WOUND ARCHITECTURE WAS COMPROMISED. THE SURGERY WAS COMPLETED NEXT DAY ON URGENT BASIS IOL WAS SUPPLIED.

  Patient problems: Insufficient Information

  MAUDE report 20378808 ↗
• MalfunctionJul 22, 2024Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19792334 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN IOL (INTRAOCULAR LENS ) IMPLANTATION PROCEDURE PATIENT EXPERIENCED PROBLEM OF LIGHT CIRCLES AROUND A LIGHT SOURCE WHEN SHE SEES A LIGHT. SHE SEES TWO LIGHT CIRCLE IN ONE EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH ONE OF THE TWO EYES.

  Patient problems: Visual Disturbances

  MAUDE report 18317815 ↗
• InjuryNov 29, 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 LIGHT SENSITIVITY AND CYSTOID MACULAR EDEMA. AS A SOLUTION, THE INITIAL LENS WAS REMOVED, AND IN A SUBSEQUENT PROCEDURE, A LENS FROM A DIFFERENT COMPANY WAS IMPLANTED. THIS RESULTED IN THE RESOLUTION OF THE PATIENT'S ISSUES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Macular Edema; Visual Disturbances

  MAUDE report 18226043 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT COULD NOT SEE THINGS CLEARLY ENOUGH IN THE INTERMEDIATE SPACE, SUCH AS SIGNS ON WALLS ETC. THE PATIENT WAS HAVING SMALL DISTANCE PRESCRIPTION WHICH THE SURGEON WAS LOOKING TO FIX WITH LASER. EIGHTEEN MONTHS POST OPERATIVELY, THE PATIENT WAS STILL EXPERIENCING GLARE, NOTICED HALOS A LOT OF TIME. IN ONE EYE, THE PATIENT WAS SEEING STREAKS OF LIGHTS COMING OFF LIGHTS, AND EVEN THE MOON. ALSO, THE PATIENT COULD NOT SEE A PERSON OR OBJECT WAS STANDING IN FRONT OF A LIGHT SOURCE, AND THIS WAS MUCH WORSE NOW WITH THE LENSES. THE PATIENT ALSO SEES GHOSTING AROUND LIGHT OBJECT, INCLUDING PEOPLE IN SUNNY ENVIRONMENTS. THE OTHER ISSUE IS THAT AT NIGHT THE PATIENT FIND CERTAIN LED LIGHTS DIFFICULT AND THE PATIENT FINDS DIFFICULT TO READ WHITE WORDS ON A BLACK BACKGROUND. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PATIENT WAS HAVING DRY EYE IMMEDIATELY AFTER THE SURGERY, AND THAT, THE PATIENT WAS SEEING STREAKS OF LIGHTS COMING OFF LIGHTS, AND EVEN THE MOON IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONALLY THE PATIENT ALSO HAD YAG PROCEDURE DONE AN YEAR AGO ON THE RIGHT EYE AND THE PATI

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

  MAUDE report 18159147 ↗
• InjuryNov 6, 2023Adverse 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 DIAGNOSED WITH ENDOPHTHALMITIS A DAY AFTER SURGERY. THE IOL WAS EXCHANGED FOR ANOTHER LENS THE SAME DAY.

  Patient problems: Endophthalmitis

  MAUDE report 18072328 ↗
• MalfunctionOct 24, 2023Scratched Material; Scratched Material

  A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ONCE IMPLANTED, SURGEON REALIZED THAT THE LENS WAS DAMAGED AND SCRATCHED. SURGEON DECIDED TO LEAVE THE LENS INSIDE THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17996590 ↗
• InjuryAug 14, 2023Break; Break

  A NURSE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE HAPTIC WAS FOUND DETACHED. THE LENS WAS EXPLANTED FROM THE EXTENDED CORNER BY ENLARGING THE INCISION TO 2.5MM. THE SURGERY WAS COMPLETED BY REPLACING WITH THE SAME MODEL AND DIOPTER LENS. THERE WERE NO COMPLICATIONS.

  Patient problems: Eye Injury

  MAUDE report 17538806 ↗
• MalfunctionMar 24, 2023Crack; Crack

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACK IN OPTIC/HAPTIC JUNCTION OF LENS, LENS NEEDED TO BE EXPLANTED WITH FORCEPS IN INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16610691 ↗
• InjuryMar 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT AFTER A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE SEES RAYS OF LIGHT IN BOTH EYES. THE DOCTOR HAD INFORMED THAT SHE WOULD IMPROVE IN AROUND 15 TO 20 DAYS, BUT SHE INFORMED THAT THE RAYS REMAIN, MAINLY AT NIGHT, MAKING IT DIFFICULT TO SEE WHEN DRIVING. SHE ALSO REPORTED THAT, SHE SAW A LINE SIMILAR TO "AN EYELASH OR HAIR", INTERFERING WITH HER VISION. SHE ALSO INFORMED ABOUT HER EYES FEEL VERY DRY, DIFFICULTY SEEING FAR AND NEAR, DIFFICULTY LOOKING IN THE MIRROR AND THAT FOR READING SHE NEEDED TO USE HER OLD GLASSES TO FOCUS ON THE LETTERS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances

  MAUDE report 16505358 ↗
• MalfunctionJun 9, 2022Crack; Crack

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CRACKS ARE NOTED WITH IN THE OPTIC ZONE WHILE CHECKING THROUGH MICROSCOPE. THE PHYSICIAN DECIDED TO REMOVE THE LENS AND REPLACED WITH OTHER COMPANY LENS. THE LENS WAS EXPLANTED THE SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642700 ↗
• MalfunctionMay 16, 2022Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE SURGEON NOTICED A LINE IN THE ENTIRE OPTIC AND DECIDED TO REMOVE IT. THE PATIENT WAS IMPLANTED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14404912 ↗
• InjuryFeb 18, 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 EXPERIENCED SEVERE HALOS DURING DAY AND NIGHT. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT DISTRACTED OVER RINGS AROUND THE LIGHT. PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13557615 ↗