AcrySof™ IQ PanOptix™ Toric UV IOL TFAT50 (REF TFAT50.230)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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652419826), received between Oct 18, 2021 and Oct 18, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of 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 16, 2026.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Fibrosis1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 18, 2021Malposition of Device; Malposition of Device
A PHYSICIAN REPORTED THAT FOLLOWING AN UNCOMPLICATED CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE AXIS OF THE IOL IS OFF. AT SIX WEEKS POSTOPERATIVE, THE PATIENT¿S CORNEA IS CLEAR AND THERE IS NO CYSTOID MACULAR EDEMA (CME). THERE IS SOME PERIPHERAL FIBROSIS OVER THE ANTERIOR SURFACE OF THE IOL. THE PATIENT HAS BEEN OFFERED AN IOL ROTATION OR IOL EXCHANGE AND WOULD PREFER THE ROTATION AT THIS TIME. THE PHYSICIAN CANNOT EXPLAIN WHY HE CAN¿T FULLY CORRECT THE PATIENT¿S VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Fibrosis; Visual Impairment
MAUDE report 12648057 ↗
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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