AcrySof IQ PanOptix Trifocal IOLRecalls & reported problems across all models
Alcon Laboratories, Inc. · 73 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 555
- Deaths reported
- 0
- Injuries reported
- 366
- Recalls
- 0
We found 73 models of AcrySof IQ PanOptix Trifocal IOL by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 555 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and Aug 19, 2026 — classified as 366 injuries, 189 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (58 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported AcrySof IQ PanOptix Trifocal IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem292
- Scratched Material58
- Defective Device42
- Break40
- Crack17
- Appropriate Device Problem Term/Code Not Available14
- Material Split, Cut or Torn14
- Device Dislodged or Dislocated13
Patient problems
- Blurred Vision169
- Visual Disturbances154
- Visual Impairment131
- No Clinical Signs, Symptoms or Conditions102
- Insufficient Information100
- Halo89
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available41
- Vitreous Floaters13
AcrySof IQ PanOptix Trifocal IOL models
73 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular42 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular39 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular35 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular35 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular30 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular25 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular21 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular19 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular18 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular17 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular17 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular13 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular13 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular12 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular10 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular10 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular10 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular9 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular9 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular8 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular8 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular8 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular7 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular7 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular7 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular6 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular6 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular6 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular5 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular4 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular4 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular4 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular3 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular2 reports
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
- AcrySof® IQ PanOptix® Trifocal IOL TFNT00Lens, multifocal intraocular1 report
Recent AcrySof IQ PanOptix Trifocal IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
A health care professional reported that following intraocular lens (IOL) implantation, the patient's vision was not enough. Consequently, the lens was explanted and replaced during a secondary procedure with a third-party lens.
Patient problems: Blurred Vision
MAUDE report 50322265 ↗MalfunctionAug 10, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50192982 ↗MalfunctionJul 17, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25854329 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EXCHANGED DUE TO THE OUTCOME AFTER THE SURGERY DID NOT MET EXPECTATIONS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE PATIENT UNDERWENT SURGERY WITH COMPANY LENS IN 2020; HOWEVER, DUE TO UNSATISFACTORY VISUAL OUTCOME, THE LENS WAS EXCHANGED TO A NON COMPANY LENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25668254 ↗MalfunctionMay 29, 2026Break
A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) SURGERY, IT WAS DISCOVERED THAT THE HAPTIC WAS BROKEN. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25331816 ↗InjuryMay 18, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD GLISTENINGS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: Visual Disturbances
MAUDE report 25199631 ↗MalfunctionMay 15, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT WAS STUCK IN THE CARTRIDGE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER UNSPECIFIED REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25184281 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS IMPLANTATION SURGERY EXCHANGE WAS PERFORMED WITH A UNSPECIFIED REPLACEMENT LENS DUE TO PATIENT INTOLERANCE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 25112212 ↗MalfunctionMay 5, 2026Failure to Deliver
A PHARMACIST REPORTED THAT THE INTRAOCULAR LENS COULD NOT BE IMPLANTED. IT WAS REPORTED THAT, THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080136 ↗MalfunctionApr 28, 2026Failure to Fold; Product Quality Problem
A PHARMACIST REPORTED THAT THE IMPLANT BENDS IN THE INCORRECT DIRECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25018747 ↗InjuryApr 1, 2026Material Deformation
A NURSE REPORTED THAT THERE WAS A PRESENCE OF MULTIPLE MICROVACUOLES CONSISTENT WITH GLISTENINGS IN AN INTRAOCULAR LENS (IOL) IMPLANTED IN A PATIENT WHO UNDERWENT CATARACT SURGERY IN 2022. IN ADDITION TO THIS FINDING, A REFRACTIVE CHANGE WAS ALSO NOTED WHEN COMPARED TO THE EXAMINATION PERFORMED TWO YEARS EARLIER. THE PHYSICIAN HAD NO INTENTION TO PERFORM AN EXPLANT AT THIS TIME. GLASSES WERE PRESCRIBED TO THE PATIENT, AND IF NEEDED, HE WOULD PERFORM A LASER TOUCH-UP. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Blurred Vision
MAUDE report 24756766 ↗MalfunctionMar 31, 2026Failure to Deliver; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE IMPLANT BLOCKED IN THE INJECTOR. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IMPLANT BROKE DURING ITS PROGRESSION INSIDE THE INJECTOR AND THERE WAS NO PATIENT CONTACT. SAME MODEL AND DIOPTER COMPANY LENS WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743621 ↗MalfunctionMar 13, 2026Device Dislodged or Dislocated; Material Deformation
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS (IOL) GOT JAMMED IN INCISION DELIVERING IMPLEMENTATION AND WAS THEREBY DEFORMED WITH PATIENT CONTACT. LOADED ANOTHER IOL WITH SAME POWER AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597691 ↗MalfunctionFeb 26, 2026Material Twisted/Bent
A NURSE REPORTED WITH DESCRIPTION OF STIFF LEGS HENCE THE LENS WAS REPLACED WITH ANOTHER STOCK LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24456071 ↗MalfunctionFeb 16, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE HAPTIC BROKEN/TORN/MISSING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE EVENT OCCURRED DURING LOADING. THERE WAS NO PATIENT CONTACT. SURGERY WAS COMPLETED USING BACKUP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24343692 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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