AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.275)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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652357883), received between Jun 3, 2022 and Aug 21, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
- Scratched Material1
Patient problems
- Eye Injury1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 21, 2023Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE SIGNIFICANT SCRATCH ON THE IMPLANTED IOL. EXPLANT REQUIRED. BACKUP IOL PLACED IN BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17585458 ↗InjuryJun 3, 2022Break; Break
A NURSE REPORTED THAT DURING A IMPLANT SURGERY, ONE HAPTIC OF THE LENS BROKEN INSIDE THE EYE. ON REMOVAL THE OTHER HAPTIC BROKE TOO. ADDITIONAL INFORMATION RECEIVED AND CONFIRMED THAT, THE PROCEDURE COMPLETED WITH AN ENLARGED INCISION PLUS SUTURE AND REMOVED BROKEN INTRAOCULAR LENS AND REPLACED WITH BACK UP IOL.
Patient problems: Eye Injury
MAUDE report 14588828 ↗
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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