AcrySof® IQ PanOptix® Toric Trifocal IOL TFNT30 (REF TFNT30U195)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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652415514), received between Jun 7, 2021 and Aug 8, 2022 — classified as 4 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Visual Impairment3
- Blurred Vision2
- Halo2
- Visual Disturbances1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2022Device Dislodged or Dislocated; Scratched Material; Device Dislodged or Dislocated; Scratched Material
A PHYSICIAN REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED HALOS AND BLUR VISION. THE LENS WAS SLIGHTLY DISPLACED AND WAS SCRATCHED. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. PATIENT RECEIVED A REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Halo; Visual Impairment
MAUDE report 15183037 ↗InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD OPTICAL SURPRISE. THE IOL EXCHANGED FOR ANOTHER LENS (ANOTHER MODEL) APPROXIMATELY ONE MONTH FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Visual Impairment
MAUDE report 12750898 ↗InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED DECREASED NEAR VISION, FIELD OF VISION DISTORTION, CONSTANT HAZY VISION PLUS GLARE AND HALOS. THE PATIENT WAS UNABLE TO ADAPT. ADDITIONAL INFORMATION WAS PROVIDED INDICATING THAT THE IOL WAS EXCHANGED FOR A DIFFERENT IOL MODEL.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 12100835 ↗InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS WAS IMPLANTED, THE PATIENT EXPERIENCED VISUAL SIDE EFFECTS. THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 5 MONTHS AFTER INITIAL IMPLANTATION. INTOLERANT TO MONOFOCAL , VISUAL DISTURBANCE WAS THE CLINICAL REASON GIVEN FOR THE EXPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 11951463 ↗
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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