AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.295)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
All models of AcrySof IQ PanOptix Trifocal IOL (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652357920), received between Apr 1, 2026 and Apr 1, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Material Deformation
A NURSE REPORTED THAT THERE WAS A PRESENCE OF MULTIPLE MICROVACUOLES CONSISTENT WITH GLISTENINGS IN AN INTRAOCULAR LENS (IOL) IMPLANTED IN A PATIENT WHO UNDERWENT CATARACT SURGERY IN 2022. IN ADDITION TO THIS FINDING, A REFRACTIVE CHANGE WAS ALSO NOTED WHEN COMPARED TO THE EXAMINATION PERFORMED TWO YEARS EARLIER. THE PHYSICIAN HAD NO INTENTION TO PERFORM AN EXPLANT AT THIS TIME. GLASSES WERE PRESCRIBED TO THE PATIENT, AND IF NEEDED, HE WOULD PERFORM A LASER TOUCH-UP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 24756766 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page