AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30.230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652390033), received between May 24, 2021 and Feb 19, 2024 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 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.

• InjuryFeb 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED POOR DISTANCE VISION, HALOS AND GLARE. THE SURGEON FELT THERE WAS POSSIBLY SOMETHING WRONG WITH THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER SAME POWER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WERE POOR DISTANCE VISION AND MYOPIC ERROR. ADDITIONAL INFORMATION WAS RECEIVED. THE IOL MOVED FORWARD LEAVING THE PATIENT WITH MYOPIC ERROR. THERE WAS NO PHYSICAL HARM, NO HOSPITALIZATION, BUT THE VISION WAS NOT AS EXPECTED. THE PATIENT'S ASSESSMENT IS ONGOING.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 18730447 ↗
• MalfunctionOct 20, 2023Mechanical Jam; Mechanical Jam

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING LENS IMPLANTATION SURGERY, PHYSICIAN FELT THAT THE LENS MATERIAL WAS HARDER THAN USUAL. HAD DIFFICULTY INSERTING INTO THE CARTRIDGE. PROCEDURE COMPLETED WITH AN ANOTHER LENS, PROCEDURE CARRY ON AS PLANNED. NO AFFECT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17976618 ↗
• InjuryOct 20, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS +5.75 AFTER REFRACTIVE LENS EXCHANGE (RLE) AND EMMETROP ON THE OTHER EYE, SO THE SUSPICION IS THAT THE LENS HAD THE WRONG POWER (THE SCANNED BARCODES SAY THAT THE INFORMATION ON THE PACKAGE MATCHED WHAT WAS PLANNED). IT WAS ALSO REPORTED THAT THERE WAS SOMETHING WRONG WITH ONE OF THE LENSES. THE PATIENT HAS RECEIVED A NEW LENS. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT CAME BACK FOR A SCHEDULED FOLLOW-UP AND REPORTED BAD VISION THE PATIENT HAD 5.75 DIAPTER ISSUE AND WAS VERIFIED UNDER EXAMINATIONS DURING THE FOLLOW-UP . THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE PATIENT WAS NOT HARMED AND AFTER THE IMPLANT THE SIGHT WAS GOOD.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 17975662 ↗
• MalfunctionAug 30, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, LENS FOUND TO HAVE FOREIGN BODY ATTACHED TO IT. THE SURGEON INSPECTED BOTH SIDES OF THE LENSES UNDER THE SCOPE BEFORE LOADING INTO CARTRIDGE BUT THEN FOREIGN MATERIAL APPEARED IN EYE. THE FOREIGN MATERIAL WAS REMOVED FROM THE EYE WITH IRRIGATION AND ASPIRATION (I/A). IT WAS DIFFICULT TO GET OFF AND THE SURGEON FELT LIKE IT WAS STUCK TO THE BACK OF THE LENS.

  Patient problems: Insufficient Information

  MAUDE report 15321927 ↗
• MalfunctionMar 29, 2022Crack; Crack

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS WAS FOUND CRACKED, SO THE LENS WAS REPLACED WITH AN EXTRA IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13940233 ↗
• MalfunctionDec 23, 2021Defective Device; Defective Device

  A PHARMACIST REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A DEFECTIVE IMPLANT. THE CORRECT INJECTOR AND CARTRIDGE WERE USED. THE IMPLANT WAS VERY VISCOUS AND WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 13079436 ↗
• InjuryAug 27, 2021Adverse 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 HAD HALOS AROUND LIGHTS. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON GIVEN FOR THE EXPLANT WAS ¿INTOLERANCE OF DYSPHOTOPSIA FROM MULTIFOCAL LENS¿. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 12378141 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT ONE YEAR FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED THAT LIGHT GLARE IS TOO SEVERE AND POOR VISION AT NEAR-DISTANCE FROM SIX MONTHS AFTER THE SURGERY. THE OPHTHALMOLOGIST EXPECTED THAT IT TAKES UP TO SOME TIME FOR THE PATIENT'S VISION TO STABILIZE AFTER SURGERY BUT THE PATIENT HAD DIFFICULTY TO ADJUST THE VISON AND DECIDED TO GET THE EXCHANGE SURGERY A YEAR AFTER CATARACT SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11870418 ↗