AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00U215)Recalls & reported problems
Alcon Laboratories, Inc. · AcrySof® IQ PanOptix® Trifocal intraocular lenses is an ultraviolet absorbing and blue light filtering foldable multifocal IOL · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652415026), received between May 7, 2021 and Apr 4, 2023 — classified as 8 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Defective Device” (2 reports).
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Defective Device2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Blurred Vision5
- Visual Disturbances5
- Insufficient Information3
- Visual Impairment3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED IN SECONDARY PROCEDURE DUE TO BLURRY NEAR VISION. IT WAS EXCHANGED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 16672108 ↗InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE IS HAVING TROUBLE WITH THE CLOSE VISION, AND IT WAS BLURRY, HE CANT FOCUS ON THE NEAR READING AND ITS DETERIORATING EACH WEEK. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT THE CLOSE FOCAL POINT (0-10 FEET) CONTINUES TO DETERIORATE AND READING OR CLOSE UP WORK IS NO LONGER POSSIBLE WITH THE RIGHT EYE AND SINCE THE IMPLANT THE VISION IS INCREASINGLY CLOUDY IN THE RIGHT EYE WHEN VIEWING OBJECTS AGAINST A LIGHT BACKGROUND. NO FURTHER INFORMATION AVAILABLE. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT POSTERIOR CAPSULE HAZE WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 16022205 ↗MalfunctionDec 14, 2022Defective Device; Defective Device
ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT DID NOT HAVE ADDITIONAL SURGERY. THE LENS WAS REMOVED AND A NEW ONE WAS PLACED DURING INITIAL PROCEDURE. THE SAME LENS SIZE WAS PUT IN.
Patient problems: Insufficient Information
MAUDE report 15975846 ↗MalfunctionDec 14, 2022Defective Device; Defective Device
A NURSE MANAGER REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS FOUND TO BE DEFECTIVE AND IT WAS EXPLANTED. PATIENT WAS LEFT APHAKIC AND SENT HOME, AND THE SURGERY WAS PLANNED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 3 OF 4. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15975751 ↗InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD MULTIPLE INCLUSIONS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 22 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14945735 ↗InjuryDec 6, 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 WAS UNHAPPY WITH VISION/VISUAL INTOLERANCE WITH MULTI-FOCAL LENS, NO VITRECTOMY, SUTURE OF LENS OR INCISION OR INCISION ENLARGEMENT NEEDED. THE CAPSULE BAG WAS INTACT. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12933761 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT SHE HAD A CATARACT SURGERY ON HER LEFT EYE AND FOLLOWING THE IOL IMPLANT PROCEDURE NIGHT DRIVING IS NEARLY IMPOSSIBLE-BRIGHT STARBURSTS ARE AROUND EVERY LIGHT AT NIGHT. EVERY HEADLIGHT, EVERY STREETLIGHT, EVERY LIGHT LOOKS LIKE A FIREWORK AND THIS HAS NOT DIMINISHED OVER TIME. SHE NEED TO HAVE THE CATARACT REMOVED FROM OTHER EYE BUT CAN¿T GET IT DONE BECAUSE SHE WONT BE ABLE TO SEE AT ALL AT NIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 12437826 ↗InjuryAug 12, 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 EXPERIENCED NIGHT VISION FUNCTIONAL PROBLEMS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL SEVEN MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 12314491 ↗InjuryJul 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT NOT HAPPY WITH VISION. PATIENT WAS VERY UPSET AS VISION UNABLE TO PUSH BEYOND 20/30 EVEN WITH REFRACTION. THE IOL WAS EXPLANTED WITH PATIENT NON ADAPT ISSUE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 12115433 ↗InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) PATIENT EXPERIENCED BLURRED VISION AND POSITIVE DYSPHOTOPSIA. THE LENS WAS EXPLANTED DURING SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING IN THE SURGEON¿S OPINION, THE PRODUCT CAUSE THE EVENT.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 11789679 ↗
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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