AcrySof™ IQ PanOptix™ Toric UV IOL TFAT60 (REF TFAT60.235)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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652420365), received between Mar 25, 2021 and Feb 4, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material1
Patient problems
- Blurred Vision1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 4, 2022Scratched Material; Scratched Material
A SURGICAL TECHNOLOGIST REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION APPROXIMATELY TEN MONTHS LATER THERE APPEARED A SCRATCH ON THE LENS AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE LENS WAS EXCHANGED AND REPLACED FOR ANOTHER LENS OF THE SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND WAS NOT HOSPITALIZED FOR THE EVENT. IT WAS FURTHER CLARIFIED THAT THE SCRATCH WAS MORE ON THE OPTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13449735 ↗InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED FOLLOWING THE IMPLANT OF AN INTRAOCULAR LENS (IOL) A PATIENT EXPERIENCED BLURRY VISION AND WAS UNHAPPY. THE LENS WAS EXCHANGED APPROXIMATELY TWO MONTHS FOLLOWING INITIAL IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 11568737 ↗
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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