AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.220)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Trifocal intraocular lenses is an ultraviolet absorbing and blue light filtering foldable multifocal IOL · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon AcrySof IQ PanOptix trifocal intraocular lens is a foldable lens implanted during cataract surgery to replace the eye's natural lens. The 35 reports mostly describe the lens cracking, breaking, or scratching as surgeons loaded or implanted it, sometimes requiring removal and a replacement lens, along with glare, halos, and blurred vision. There were 17 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380652357777), received between Apr 7, 2021 and May 18, 2026 — classified as 17 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Defective Device” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Defective Device6
- Break5
- Scratched Material5
- Appropriate Device Problem Term/Code Not Available3
- Failure to Advance3
- Application Program Problem: Power Calculation Error1
- Crack1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions8
- Visual Disturbances5
- Visual Impairment5
- Blurred Vision4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Halo3
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLISTENINGS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: Visual Disturbances
MAUDE report 25199631 ↗MalfunctionFeb 26, 2026Material Twisted/Bent
A NURSE REPORTED WITH DESCRIPTION OF STIFF LEGS HENCE THE LENS WAS REPLACED WITH ANOTHER STOCK LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24456071 ↗MalfunctionNov 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS HAD BEEN FULLY INJECTED AND THE LENS OPENED IN THE EYE, THE SURGEON NOTICED A CRACK IN THE MIDDLE OF THE LENS. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS USING A NEW SAME COMPANY CARTRIDGE INJECTOR AND VISCOELASTIC DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A DELAY OF 5 MINUTES IN THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23578135 ↗MalfunctionSep 12, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, LENS PRESENTED AN OPACITY AND A RISK POINT IN THE CENTRAL HALO, REQUIRED AN EXPLANATION OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING, WHEN IMPLANTING THE IOL, THE DOCTOR NOTICED AN OPACITY AND MARK. THE LENS WAS THEN EXPLANTED AND A NEW ONE IMPLANTED ON THE SAME DAY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23041986 ↗InjuryJan 22, 2025Defective Device; Defective Device
ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE EXCHANGE WAS PERFORMED DUE TO HAPTIC NOT SUPPORTING THE CHAMBER WELL.
Patient problems: Insufficient Information
MAUDE report 21206699 ↗MalfunctionJan 20, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS LOOP BROKEN DURING LOADING PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21190655 ↗MalfunctionDec 4, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS DEFECT IN CENTER OF LENS. THE LENS WAS REMOVED AND SECOND SPARE LENS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED, WHEN THE LENS WAS INSERTED DOCTOR OBSERVED A DEFECT WHICH HE SAID WAS FROM THE WAY THE LENS HAD BEEN FOLDED. THE PATIENT HAS BEEN SEEN POST OPERATIVELY AND WAS DUE FOR A FURTHER CHECK UP IN FOUR WEEKS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20840824 ↗InjurySep 20, 2024Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS BROKEN UPON EJECTION FROM INJECTOR. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. OPERATION RESCHEDULED AND ANOTHER NEW UNSPECIFIED IOL WAS IMPLANTED ONE WEEK LATER. NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20266861 ↗InjuryJul 17, 2024Material Opacification; Material Opacification
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WORSENING OF VISION. A CENTRAL OPACITY WAS OBSERVED IN THE IOL DURING THE POST-SURGERY VISIT AND DOCUMENTED WITH PHOTOGRAPHS AT THE SLIT LAMP. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19766519 ↗InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO ADAPT TO DAILY LIFE DUE TO RESIDUAL ASTIGMATISM AND REFRACTIVE ERROR. THE LENS WAS EXCHANGED 1 MONTH FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 19379821 ↗MalfunctionNov 28, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SEVERE GLISTENING APPEARED AFTER 1 YEAR FROM SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE 1ST EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18214411 ↗MalfunctionNov 23, 2023Defective Device; Malposition of Device; Defective Device; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THE HAPTIC OF THE LENS WAS BROKEN. THE PHYSICIAN IMPLANTED THE SAME LENS INTO THE PATIENT'S EYE AND POST OPERATIVE DAY 1, THE LENS WAS DECENTERED. THE PHYSICIAN HAS PLANNED TO EXPLANT THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS HAS BEEN EXPLANTED AND THE PATIENT WAS RECOVERED.
Patient problems: Insufficient Information
MAUDE report 18198987 ↗MalfunctionSep 7, 2023Break; Failure to Eject; Break; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), LENS WAS LOADED INTO THE INJECTOR CARTRIDGE UNDER VISCOELASTIC SUBSTANCE WITHOUT PROBLEMS. WHILE IMPLANTING, PASSAGE IOL INSIDE THE CARTRIDGE, NOTICED A GREATER RESISTANCE THAN USUAL. AFTER INJECTING THE LENS INTO THE EYEBALL, THE FIRST COMPLETELY AMPUTATED HAPTIC CAME OUT OF THE OPTIC, LEAVING THE ANTERIOR CHAMBER FREE, WITHDREW THE INJECTOR AND PROCEEDED TO REMOVE THE HAPTIC. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS LEFT APHAKIC DURING THE INITIAL PROCEDURE. NEW LENS WAS IMPLANTED IN A SECONDARY PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17698683 ↗MalfunctionJun 26, 2023Failure to Advance; Failure to Advance
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, THE LENS WOULD NOT EJECT PROPERLY FROM THE END OF THE CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17198267 ↗InjuryMay 3, 2023Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY VISUAL OUTCOME VA 6/9.5 N8, HAD POST OPERATIVE INFLAMMATION, DRY EYE AND ROSACEA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. AFTER REPLACING ANOTHER LENS MODEL, THE PATIENT STILL HAVING ISSUES WITH INFLAMMATION, HOWEVER THE VISION QUALITY IS BETTER.
Patient problems: Blurred Vision; Dry Eye(s); Inflammation; Rash
MAUDE report 16860244 ↗InjuryApr 11, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REDUCED VISION. SURGEON OBSERVED GLISTENING IN LENS. HAS PERFORMED YAG CAPSULOTOMY TO THE LEFT EYE TO ASSESS IMPROVEMENT TO VISION. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE EYE WAS AROUND 6/9.5 UNAIDED AND CORRECTED TO 6/6 WITH A SMALL MYOPIC CORRECTION. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LEFT EYE FEELS CLOUDY AND WAS OFFERED SULCOFLEX FOR RESIDUAL REFRACTIVE ERROR.
Patient problems: Blurred Vision
MAUDE report 16712264 ↗InjuryMar 17, 2023Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, ONCE LENS WAS INSIDE THE CAPSULAR BAG, INITIAL THOUGHT TO BE DEBRIS/VISCOELASTIC BUT EVENTUALLY NOTED TO BE DEFECT. THE LINEAR DEFECT @10 O'CLOCK PARACENTRAL WAS NOTED. THE LENS IMPLANTED AND REMOVED DURING INITIAL PROCEDURE. THE SURGERY TIME WAS LENGTHENED AND EXPOSES CORNEAL ENDOTHELIUM TO POTENTIALLY MORE DAMAGE. ALSO STATED THAT STILL THE PATIENT IS HAVING CORNEAL EDEMA, PROLONGED CORNEAL EDEMA DUE TO EXTENDED SURGERY MONITORING FOR CATARACT RESOLUTION.
Patient problems: Corneal Edema
MAUDE report 16563363 ↗MalfunctionJan 11, 2023Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE LENS GOT STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16136956 ↗MalfunctionJan 11, 2023Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE LENS GOT STUCK IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16136955 ↗MalfunctionJan 5, 2023Crack; Defective Device; Crack; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEFECT WAS FOUND IN IOL. THERE WAS A PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16101459 ↗InjuryDec 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REDUCED VISION. SURGEON OBSERVED GLISTENING IN LENS. HAS PERFORMED YAG CAPSULOTOMY TO THE LEFT EYE TO ASSESS IMPROVEMENT TO VISION. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.
Patient problems: Blurred Vision
MAUDE report 16047901 ↗MalfunctionSep 20, 2022Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE SURGERY, THE LENS WAS DAMAGED AND WAS LENS WAS REPLACED. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15454404 ↗MalfunctionJun 22, 2022Scratched Material; Scratched Material
AN OPHTHALMIC SURGEON REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR NOTICED A SCRATCH MARK ONCE THE LENS WAS INSIDE THE PATIENTS EYE. PROCEDURE WAS COMPLETED BY EXPLANTING THE LENS AND USING BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14771186 ↗InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD A HARD TIME TO SEE ANYTHING. IT MIGHT ALSO BE DUE TO TEAR FILM ISSUES. IT WAS FURTHER REPORTED THAT PATIENTS WITH PARKINSON'S MAY NOT BE ABLE TO ADAPT TO MULTIFOCALITY OF LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 14522372 ↗MalfunctionApr 25, 2022Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE INJECTOR OVER RODE THE LENS. THE LENS WAS RELOADED, THERE WAS A BROKEN AND THERE WAS SCRATCH ON THE LENS. THE LENS WAS EXPLANTED AND BACK UP LENS WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14193968 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page