AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT50 (REF TFNT50U275)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 18, 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 00380652416733), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (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.
Reports received per month
Most reported problems
Device problems
- Defective Device1
Patient problems
- Blurred Vision1
- Dry Eye(s)1
- Halo1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2024Defective Device; Defective Device
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MAJOR ISSUES WITH LIGHTS (STARS, CIRCLES), NEGATIVE DYSPHOTOPSIA (ND), ASTIGMATISM NOT BEING CORRECTED, EXTREME DRYNESS, LOSS OF SHARPNESS AT LONG DISTANCES, HALOS, GLARE, AND STARS. IN THE LAST APPOINTMENT WITH THE SURGEON, IT WAS REVEALED THAT THERE WAS A BREAKDOWN IN THE MATERIAL OF THE LENS, DESCRIBED AS DOTS OR BUBBLES, CAUSING VISION ISSUES FOR THE PATIENT. THERE WAS A PLANNED EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Dry Eye(s); Halo; Visual Disturbances; Visual Impairment
MAUDE report 20612321 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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