AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652357845), received between Mar 11, 2021 and Aug 1, 2023 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2023Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED LENS HAD A CRACK THROUGH THE MICROSCOPE, WHEN TRIED TO REMOVE IT FROM THE BAG IT ENDED UP BREAKING, REPORTED NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432209 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD COMPLAINED OF A YELLOW TINGE IN THE VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT HAD UNDERGONE A YAG SURGERY A MONTH AGO AND HAD DONE OCT SCANS FOR THE MACULA WHICH APPEARED TO BE NORMAL. EVEN AFTER PERFORMING A YAG THE SYMPTOMS DID NOT RESOLVE. THERE WERE NO OTHER OCULAR CO-MORBIDITIES TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED.

  Patient problems: Visual Impairment

  MAUDE report 17360984 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT REFRACTIVE ERROR WAS S+0.5 C-0.75. THE PATIENT COMPLAINED OF DECREASED VISUAL ACUITY AND DISCOMFORT WITH A DISTANCE 0.3 CORRECTION OF 0.4. THE LENS EXCHANGE PROCEDURE WAS PERFORMED WITH A SINGLE PIECE OF SENSOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Discomfort; Visual Impairment

  MAUDE report 15788265 ↗
• InjuryMay 23, 2022Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FRACTURED DURING PLACEMENT CAUSING PAIN TO THE PATIENT. ONE WEEK LATER, THE DAMAGED IOL WAS REMOVED AND REPLACED FOR ANOTHER LENS DURING A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE AFFECTED EYE WAS THE RIGHT EYE AND THE IMPACT ON THE PATIENT WAS PAIN AND BLURRED VISION. THE PATIENT ISSUE WAS RESOLVED.

  Patient problems: Blurred Vision; Eye Pain

  MAUDE report 14476198 ↗
• MalfunctionApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION THROUGH A MULTIFOCAL IOL AND INCOMPATIBILITY OF VISION BETWEEN THE TWO EYES. NO FURTHER INFORMATION IS EXPECTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14170058 ↗
• MalfunctionMar 16, 2022Scratched Material; Scratched Material

  A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS WAS SCRATCHED HENCE WAS NOT USED. ANOTHER BACK UP LENS OF THE SAME MODEL AND A DIFFERENT DIOPTER WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13787490 ↗
• InjuryMar 31, 2021Malposition of Device; Malposition of Device

  A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF AN INTRAOCULAR LENS (IOL), A PATIENT EXPERIENCED AN UNEXPECTED REFRACTIVE ERROR AND THE LENS WAS TILTED. THE PATIENT'S VISUAL ACUITY DECREASED. THE LENS WAS EXCHANGED DURING A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

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

  MAUDE report 11596207 ↗
• MalfunctionMar 11, 2021Scratched Material; Scratched Material

  A CUSTOMER REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS SCRATCHED AND THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING, THAT THE LENS WAS INJECTED WITH AN INCISION INJECTOR AND WHEN IT WAS ADVANCED A FEW MILLIMETER FROM THE OUTLET, A PART OF THE LENS WAS SEEN TO BE EXITING BY OPENING ON THE SIDE OF THE INJECTOR CARTRIDGE THAT HAD A SMALL LINEAR OPENING. LENS WAS WITHDRAWN AND RETREATED. UPON INSPECTION, IT HAD STRIATIONS IN THE OPTIC AREA AND IT WAS DECIDED TO REPLACE IT. A BACK UP LENS WAS USED AND PROCEDURE WAS CONCLUDED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464940 ↗