AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT40 (REF TFNT40U145)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 00380652415941), received between Apr 1, 2021 and Apr 1, 2021 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
- Malposition of Device1
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.
InjuryApr 1, 2021Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED A LENS EXCHANGE DUE TO GLISTENINGS. ADDITIONAL INFORMATION RECEIVED; THE PATIENT COMPLAINED OF REDUCED AND CLOUDY VISION. SHE DESCRIBES HER VISION AS "BLURRY" AND "OUT OF FOCUS". SHE STATES THAT HER DECREASED VISION IS MODERATELY SYMPTOMATIC. THIS VISUAL PROBLEM IS MOST NOTICEABLE WHEN DRIVING, IN THE MORNINGS, WHEN READING AND WHEN WATCHING TELEVISION. THE IOL WAS DECENTERED INFERIORLY AND YAG CAPSULOTOMY PERFORMED. THE PATIENT HAD A LENS EXCHANGE WITH A PLANNED ANTERIOR VITRECTOMY DUE TO AN OPEN POSTERIOR CAPSULE APPROXIMATELY 18 MONTHS FOLLOWING THE INITIAL SURGERY. A THREE PIECE MONOFOCAL IOL WAS IMPLANTED IN THE SULCUS. THE PATIENT HAS SIGNIFICANT ASTIGMATISM AND WILL REQUIRE PRK IN THE FUTURE TO RESOLVE THE RESIDUAL REFRACTIVE.
Patient problems: Blurred Vision
MAUDE report 11605652 ↗
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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