AcrySof™ IQ PanOptix™ UV IOL TFAT00 (REF TFAT00.165)Recalls & reported problems
Alcon Laboratories, Inc. · The AcrySof® IQ PanOptix® UV Absorbing Trifocal intraocular lenses (IOLs) are ultraviolet absorbing foldable multifocal IOLs · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652429641), received between Apr 28, 2022 and Feb 26, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Failure to Align1
Patient problems
- Blurred Vision2
- Eye Pain1
- Halo1
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS OTHER MECHANICAL COMPLICATIONS OF LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 21468292 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT CAUSE OF THE EVENT WAS LACK OF NEUROADAPTATION. THERE WAS NO PATIENT HARM.
Patient problems: Halo
MAUDE report 18994390 ↗InjuryDec 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXPLANTED DUE TO THE PATIENT'S REPORT OF A TREMBLING LENS. THE CLINICAL REASON IDENTIFIED WAS A MALFUNCTIONING IOL, SPECIFICALLY PHACODENESIS. THE IOL WAS SUBSEQUENTLY REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 18281623 ↗InjurySep 25, 2023Failure to Align; Failure to Align
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT COMPLAINED OF EYE PAIN AND CONTINUED BLURRY VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS LENS DISLOCATION. ADDITIONAL INFORMATION WAS RECEIVED. THE IOL EXCHANGE WAS DONE IN RIGHT EYE WITH COMPANY LENS. IN THE SURGEON'S OPINION, THE EVENTS WERE CAUSED DUE TO DISLOCATION OF LENS. THE PATIENT WAS FULLY RECOVERED AFTER LENS EXCHANGE.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 17809334 ↗InjuryApr 28, 2022Adverse 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 EXPERIENCED POOR VISION AND REDUCED ASTIGMATISM. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 14238542 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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