AcrySof™ IQ PanOptix™ Toric UV IOL TFAT40 (REF TFAT40.115)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix Toric UV IOL (120)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652419062), received between Nov 28, 2021 and Dec 8, 2023 — classified as 3 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Dislodged or Dislocated1
Patient problems
- Visual Disturbances2
- Halo1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED AN THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD REFRACTIVE SURPRISE HYPEROPIA. CLINICAL REASON WAS MENTIONED AS ANISOMETROPIA. THE IOL WAS EXCHANGED WITH IN A WEEK FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 18289922 ↗InjuryDec 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED AND STATED THAT 40 11.5 LENS WAS EXCHANGED FOR A 4 11.0 LENS DUE TO HALOS, PHOTOPSIA, GLARE. THIS DOES NOT MEET CRITERIA FOR REPORTING BASED ON APPLICABLE MEDICAL DEVICE REGULATIONS. A LENS EXCHANGE FROM ONE POWER TO A DIFFERENT POWER IS AN ATTEMPT TO ADJUST OR FINE TUNE THE REFRACTIVE OUTCOME TRYING TO ACHIEVE A DESIRED TARGET WHEN THE INITIAL LENS CALCULATIONS DID NOT ACHIEVE THE INTENDED OUTCOME. THERE IS NO REPORTED DEFECT OR FAULT WITH THE LENS.
Patient problems: Halo; Visual Disturbances
MAUDE report 13125372 ↗InjuryNov 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH THE OUTCOME. THE TORIC LENS SHIFTED WITH UNDERCORRECTION. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL APPROXIMATELY 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12880026 ↗
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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