AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT50 (UDI 00380652391061)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Toric Trifocal intraocular lenses (IOLs) are ultraviolet absorbing and blue light filtering foldable multifocal IOLs · Class 3 · Implant
All models of AcrySof IQ PanOptix Toric Trifocal IOL (165)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652391061), received between May 10, 2024 and May 10, 2024 — classified as 1 injury.
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
- Device Dislodged or Dislocated1
- Material Opacification1
Patient problems
- Blurred Vision1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2024Material Opacification; Device Dislodged or Dislocated; Material Opacification; Device Dislodged or Dislocated
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, TWO DAYS AFTER THE IMPLANT PROCEDURE SURGEON NOTICED THAT THERE WAS A WHITE SPOT, AS IF IT WERE A FOG, AND THIS MAKES PATIENT SEE EVERYTHING BLURRY, TO TRY TO READ SOMETHING, PATIENT HAS TO CLOSE LEFT EYE. PATIENT RETURNED TO THE DOCTOR AND WAS TOLD THAT IT WOULD GO AWAY OVER THE DAYS, BUT THERE WAS NO IMPROVEMENT AND AFTER 6 MONTHS, PATIENT HAD THE LENS CLEANED, AND IT DID NOT RESOLVE, AND RETURNED TO THE DOCTOR AND WAS TOLD THAT THERE COULD HAVE BEEN A DISPLACEMENT OF THE LENS, AND A PROCEDURE WAS PERFORMED TO TRY TO PUT THE LENS IN THE RIGHT PLACE AND REPORTED THAT IT DID NOT IMPROVE AND IT GOT EVEN WORSE.
Patient problems: Blurred Vision
MAUDE report 19286783 ↗
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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