AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380652357760), received between Mar 5, 2021 and May 29, 2026 — classified as 24 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Break

  A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) SURGERY, IT WAS DISCOVERED THAT THE HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. 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 25331816 ↗
• MalfunctionMar 13, 2026Device Dislodged or Dislocated; Material Deformation

  A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS (IOL) GOT JAMMED IN INCISION DELIVERING IMPLEMENTATION AND WAS THEREBY DEFORMED WITH PATIENT CONTACT. LOADED ANOTHER IOL WITH SAME POWER AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597691 ↗
• MalfunctionJan 8, 2026Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS TORN, AND THE SURGERY WAS COMPLETED WITHOUT HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016706 ↗
• MalfunctionDec 19, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. THE SURGERY COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23854209 ↗
• MalfunctionAug 13, 2025Product Quality Problem; Product Quality Problem

  A NURSE REPORTED WITH A DESCRIPTION THAT THE IMPLANT WAS DEFECTIVE. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22792509 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR IMPLANT PROCEDURE, ONE WEEK AFTER DISCHARGE, THERE WAS A SEVERE HALO AND GLARE AT NIGHT, WHICH AFFECTED DRIVING. THE DOCTOR ADVISED THE PATIENT TO CONTINUE OBSERVATION AND RECOMMENDED TO UNDERGO IOL REPLACEMENT SURGERY AND IMPLANT ANOTHER LENS.

  Patient problems: Visual Disturbances

  MAUDE report 22714844 ↗
• InjuryJul 11, 2025Product Quality Problem; Product Quality Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT 5 YEARS 11 MONTHS 4 DAYS AGO THE PATIENT UNDERWENT CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. FOLLOWING THAT, THE PATIENT RETURNED TO THE CLINIC AND THE LENS WAS EXAMINED WITHIN THE EYE, AND IT WAS DECIDED TO HAVE IT REPLACED. THE IOL WAS EXCHANGED FOR ANOTHER LENS 5 YEARS 11 MONTHS 15 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22477389 ↗
• MalfunctionJan 31, 2025Scratched Material; Scratched Material

  A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE SURGEON NOTICED A SCRATCH IN THE CENTER OF THE IOL. THE SURGEON DECIDED TO CUT IOL OUT RIGHT AWAY AND INSERTED A NEW SAME MODEL SAME DIOPTER COMPANY IOL DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282330 ↗
• MalfunctionDec 12, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTICS WAS FOUND TO BE DAMAGED WHEN IT CAME FROM CARTRIDGE. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20911324 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER SURGERY, HYPEREMIA FINDINGS BEGAN IN BOTH EYES ONE MONTH POSTOPERATIVELY WERE INITIALLY CONTROLLED WITH TOPICAL TREATMENT BUT LATER PROGRESSED TO UVEITIS, WITH INCREASING SEVERITY. SYSTEMIC RHEUMATOLOGIC TESTS WERE CONDUCTED, AND NO ETIOLOGY WAS FOUND. TOPICAL STEROID TREATMENT WAS STILL BEING ADMINISTERED, BUT THE UVEITIS REMAINS UNCONTROLLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR THE LEFT EYE.

  Patient problems: Hyperemia; Uveitis

  MAUDE report 20047854 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER SURGERY, HYPEREMIA FINDINGS BEGAN IN BOTH EYES ONE MONTH POSTOPERATIVELY WERE INITIALLY CONTROLLED WITH TOPICAL TREATMENT BUT LATER PROGRESSED TO UVEITIS, WITH INCREASING SEVERITY. SYSTEMIC RHEUMATOLOGIC TESTS WERE CONDUCTED, AND NO ETIOLOGY WAS FOUND. TOPICAL STEROID TREATMENT WAS STILL BEING ADMINISTERED, BUT THE UVEITIS REMAINS UNCONTROLLED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR THE RIGHT EYE.

  Patient problems: Hyperemia; Uveitis

  MAUDE report 20047472 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH THE VISION FACING EXCESSIVE LIGHT DURING THE DAY TIME ALSO. THE PATIENT EXPERIENCED EXCESSIVE BRIGHT AND FLASHES AROUND THE EYE. HE ALSO HAD DIFFICULTY READING HAND WRITING ON WHITE PAPER, DIFFICULTY IN DISTINGUISHING BLACK LETTERS ON WHITE BOARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT HE EXPERIENCED GLARE, POOR READING ABILITY IN BRIGHT LIGHT, INCREASED REFLECTION OF WHITE LIGHT, HALOS TO SEE SIGNALS AND INABILITY TO READ LETTERS IN WHITE BACKGROUND. ISSUE WAS DISCOVERED AFTER FEW DAYS TO MONTHS AFTER SURGERY. THE ORIGINALLY SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY. THE NATURE OF LENS CONTRIBUTED TO THE EVENT AS PER THE SURGEONS OPINION. GLARE WAS DUE TO LENS OPTICAL DESIGN. THE PATIENTS ISSUES DID NOT RESOLVE. SURGEON PLANNING AN LENS EXCHANGE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18911679 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR IMPLANTATION SURGERY, THE PATIENT WAS UNHAPPY WITH THE VISION FACING EXCESSIVE LIGHT DURING THE DAY TIME ALSO. THE PATIENT EXPERIENCED EXCESSIVE BRIGHT AND FLASHES AROUND THE EYE. THE PATIENT ALSO HAD DIFFICULTY READING, HAND WRITING ON WHITE PAPER, DIFFICULTY IN DISTINGUISHING BLACK LETTERS ON WHITE BOARD, EXCESSIVE POSTERIOR CAPSULE OPACIFICATION IN HIS LEFT EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PATIENT EXPERIENCED GLARE, HALOS, POOR READING ABILITY IN BRIGHT LIGHT . INCREASED REFLECTION OF WHITE LIGHT, INABILITY TO SEE SIGNALS, INABILITY TO READ LETTERS IN WHITE BACKGROUND. DIAGNOSIS OF THE HARM WAS GLARE DUE TO LENS OPTICAL DESIGN. THE PATIENT'S ISSUE HAS NOT RESOLVED AND SURGEON IS PLANNING TO PERFORM LENS EXCHANGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Posterior Capsule Opacification; Visual Disturbances

  MAUDE report 18885915 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SYMPTOMS WERE STILL ONGOING AND PATIENT SAID THE LIGHTS OF CARS WERE GLARING HAVE SORT OF RAYS AROUND THEM. PATIENT GET TIRED AT HOME DURING CUTTING AND READING. THE EYES WERE PINCHING ALL DAY.

  Patient problems: Blurred Vision; Photophobia

  MAUDE report 18844339 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED ABOUT AN INTRAOCULAR LENS (IOL) EXPLANT DUE TO PATIENT EXPERIENCED VISUAL ACUITY, PERCEIVING LIGHT STRETCHING HORIZONTALLY WHEN EXPOSED TO NIGHTTIME ILLUMINATION. LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE IOL WAS REPLACED WITH UNSPECIFIED LENS TEN MONTHS AFTER INITIAL PROCEDURE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18476319 ↗
• MalfunctionNov 15, 2023Break; Break

  AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, AS THE SECOND HAPTIC WAS LEAVING THE CARTRIDGE TO ENTER THE ANTERIOR CHAMBER, IT WAS TORN BY THE INJECTOR. AS A RESULT, THE IOL WAS IMPLANTED BUT DID NOT REMAIN STABLE IN THE CORRECT POSITION, AND HAD TO BE EXPLANTED DURING THE SAME OPERATION. THE SURGEON USED ANOTHER BACKUP COMPANY LENS. THE SURGEON HAD LOT OF INCONVENIENCE DUE TO THE DIFFICULTY IN EXPLANTING THE IOL. THE INCREASED SURGICAL TIME LED TO A POST-OPERATIVE PERIOD WITH MORE INFLAMMATORY REACTION AND CORNEAL EDEMA. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Corneal Edema; Inflammation

  MAUDE report 18138942 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT HAD CLOUDY VISION. THE PATIENT ALSO HAD INFECTION IN THE EYE, CONTINUING TO OBSTRUCT THE FIELD OF VIEW IN THE FORM OF CLOUDS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 17662207 ↗
• MalfunctionJun 22, 2023Defective Device; Device Contamination with Chemical or Other Material; Defective Device; Device Contamination with Chemical or Other Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMAGES IN THE FORM OF TWO DOTS APPEARED IN THE RIGHT EYE. THE SPOTS WERE MOVING IN THE DIRECTION THE EYE WAS FOCUSED ON (WITH THE EYE). THE PATIENT WAS EXAMINED BY TWO DIFFERENT SPECIALIST DOCTORS. AS A RESULT OF THE EXAMINATION, THEY SAID THAT "THERE IS NO INTERVENTION OR DRUG TREATMENT TO BE DONE, THERE IS NO POSSIBILITY OF CHANGE OR INTERVENTION DUE TO THE MULTIFOCAL LENS ATTACHED. THE DOTS/SHAPES APPEAR TO BE SCATTERED (CURRENT SITUATION: POLLUTION ON THE GLASS). THERE IS DENSITY AT THREE POINTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17182148 ↗
• InjuryApr 28, 2023Break; Break

  AN HEALTHCARE PROFESSIONAL REPORTED ABOUT A LENS HAPTIC BROKEN AND THE INJECTOR TIGHTENING AND IT WENT ALREADY A BIT RIGID DURING THE PROCEDURE. THE LENS WAS EXPLANTED AND REPLACED IN A SECONDARY PROCEDURE IN A NEW OPERATION ROOM.

  Patient problems: Insufficient Information

  MAUDE report 16830896 ↗
• MalfunctionApr 10, 2023Malposition of Device; Malposition of Device

  A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD OUT OF FOCUS (+/-15 %) WHICH IS PRIMARILY DUE TO GREY GHOSTING IMAGES AS PER SURGEONS OPINION. FOR INSTANCE, A VERTICAL POLE WILL HAVE AN ASSOCIATED IMAGE TO THE LEFT. SIMILARLY THERE APPEARS TO BE GHOST LIKE IMAGES ABOVE OBJECTS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THE BLURRY VISION HAS PERSISTED AS OF DATE 1 AND DOES NOT SEEM TO IMPROVE. THE UNDERLYING FOCUS APPEARS TO BE SPOILED BY A GHOST GREY IMAGE TO THE LEFT OF A TALL POLE AND A GHOSTLY IMAGE ABOVE A HORIZONTAL IMAGE. SURGEON IS SUSPECTING THAT THE IMPLANTED LENS IS SLIGHTLY OFF CENTER WHICH THEN CREATES THESE ADDITIONAL IMAGES. ADDITIONAL INFORMATION RECEIVED AND STATED THAT RIGHT EYE IS NOT FOCUSING LEFT EYE, THERE WAS ANY PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16708168 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DENTIST REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS, COULD NOT DRIVE AT NIGHT, HAD TO WEAR SUNGLASSES ALL DAY AND NIGHT. PATIENT WANTED TO HAVE LENS REMOVED BUT WAS TOLD SHE COULD GO BLIND. HER RIGHT EYELID ALMOST WAS CLOSED SHUT BY THE END OF THE DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 16156240 ↗
• MalfunctionDec 14, 2022Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED LENS WAS IMPLANTED AND EXPLANTED AS IT WAS FOUND TO BE DEFECTIVE. THE PATIENT WAS LEFT APHAKIC AND SENT HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15976516 ↗
• MalfunctionDec 14, 2022Defective Device; Defective Device

  A NON HEALTHCARE PROFESSIONAL REPORTED LENS WAS IMPLANTED AND EXPLANTED AS IT WAS FOUND TO BE DEFECTIVE. THE PATIENT WAS LEFT APHAKIC AND SENT HOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15976089 ↗
• InjuryDec 13, 2022Adverse 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 CONSUMER NOT SEEING THE WAY SHE SHOULD AND CANNOT SEE UP CLOSE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT SHE IS HAPPY WITH DRIVING AND NIGHT DRIVING VISION. IT WAS MUCH IMPROVED. SHE WAS NOT ABLE TO READ SMALL PRINT IN BOOKS OR READ HER COMPUTER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 15968438 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED NIGHT HALOS, INTERMEDIATE VISION DEFICIT. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 6 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 15691745 ↗