AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.250)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof® IQ PanOptix® UV Absorbing Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix UV IOL (28)
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 00380652429818), received between Dec 15, 2022 and Jan 25, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE PATIENT'S SYMPTOMS WERE RESOLVED POST LENS REPLACEMENT WITH MONOFOCAL LENS. THE IOL WAS EXCHANGED FOR THE MONOFOCAL LENS MODEL BUT HALF A DIOPTER LESS POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL.
Patient problems: Blurred Vision
MAUDE report 16241032 ↗MalfunctionDec 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LITTLE DE-CENTERED BUT CENTER RING WAS WITHIN PUPILLARY SPACE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15986342 ↗
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