AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40.195)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing and blue light filtering foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix Toric Trifocal IOL (165)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652390514), received between May 3, 2022 and May 20, 2026 — classified as 5 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Material Opacification” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Material Opacification2
- Scratched Material2
- Break1
- Device Dislodged or Dislocated1
- Material Deformation1
Patient problems
- Blurred Vision4
- Visual Disturbances3
- Dry Eye(s)1
- Visual Impairment1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2026Material Opacification; Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT COMPLAINING OF BLURRED VISION 6 YEARS POST CATARACT AND IOL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT EXPERIENCED HAZY IOL, GLISTENINGS AND THE LENS WAS PLANNED TO BE EXPLANTED.
Patient problems: Blurred Vision
MAUDE report 25230719 ↗InjuryOct 23, 2023Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
THE SYMPTOMS WERE RESOLVED AND THE PATIENT IS STABLE.
Patient problems: Visual Impairment
MAUDE report 17984263 ↗InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES . THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT MENTIONED AS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 17080773 ↗InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND REPORTED THAT THE IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL BUT SAME DIOPTER POWER INDICATING THE CORRECT LENS WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision
MAUDE report 17010929 ↗MalfunctionApr 27, 2023Material Opacification; Scratched Material; Material Opacification; Scratched Material
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED VISION DISCOMFORT AND BLURRED VISION. IN THE SLIT LAMP THE LENS HAS SOME MARKS/OPACITIES ON BOTH THE FRONT AND THE BACK OF THE LENS. ADDITIONAL INFORMATION WAS RECEIVED AS THE LENS SEEMED SCRATCHED ON BOTH SIDES, THE PATIENT WAS MORE COMFORTED FOR NOW, PATIENT HAD NOT EXPLANTED THE LENS.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16822399 ↗MalfunctionOct 11, 2022Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INTRAOCULAR LENS HAD "DOTS/MARKS" ON THE SURFACE AND THE PATIENT EXPERIENCED VISUAL DISCOMFORT AT NIGHT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH FILE 1 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 15576615 ↗InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE VISION BEGAN TO FAIL AND ALSO HAD DRY EYE. THE DOCTOR PERFORMED LAZER TREATMENT ON ONE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE 2 MEDICAL RECORDS ASSOCIATED WITH THIS EVENT. THIS IS FOR THE RIGHT EYE.
Patient problems: Blurred Vision; Dry Eye(s)
MAUDE report 14270326 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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