AcrySof® IQ PanOptix® Trifocal IOL TFNT00 (REF TFNT00.230)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
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652357791), received between Mar 8, 2021 and Jun 19, 2025 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Crack4
- Scratched Material4
- Break2
- Defective Component1
- Defective Device1
- Dent in Material1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information6
- Visual Disturbances4
- Blurred Vision3
- Halo3
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Dry Eye(s)1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED THERE WAS A SCRATCH OR MARK ON OPTIC. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DEFECT NOTICED BY THE SURGEON WAS A SCRATCH ON THE OPTICAL PLATE OF THE LENS, MORE PRECISELY IN THE CENTRAL PART, THEY DECIDED TO CUT THE LENS AND REMOVE IT AND THEN INSERT THE BACKUP LENS. PROCEDURE WAS COMPLETED ON SAME DAY BY USING BACKUP LENS. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22292748 ↗MalfunctionMay 26, 2025Material Opacification; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS IMPLANT HAS OPACIFIED SHE SEES 6/30 WITH DIFFICULTY AND HAD SEEN 6/6 PREVIOUSLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 22084948 ↗MalfunctionOct 25, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY, THEY HAVE NOTICED THAT THE LENS WERE DEFECTS BEFORE THEY WERE IMPLANTED. SO, THE SURGERY WAS DELAYED BY 2 MINUTES. NO PATIENT WAS AFFECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531574 ↗InjuryJul 15, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED, THAT AFTER THE IMPLANTATION OF INTRAOCULAR LENS (IOL), DURING PHYSICIANS CONSULTATION. THERE WAS A RELEVANT SCRATCH ON THE LENS. THE LENS WAS REMOVED IN A SECONDARY PROCEDURE. ACCORDING, TO THE ADDITIONAL INFORMATION RECEIVED. THE SURGERY WAS COMPLETED USING ANOTHER LENS IN A SECONDARY PROCEDURE. THERE WAS NO HOSPITALIZATION REQUIRED.
Patient problems: Insufficient Information
MAUDE report 19740232 ↗MalfunctionJan 8, 2024Dent in Material; Dent in Material
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS ( IOL) WITH STRIPE IN THE CENTER OF THE OPTICS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18463266 ↗InjuryNov 10, 2023Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED WITH A DESCRIPTION OF WHEN THE IOL WAS ALREADY IN THE CAPSULAR BAG, THE SURGEON, WHILE ADJUSTING THE HAPTIC ELEMENTS, DISCOVERED THAT ONE OF THE HAPTICS HAD A TEAR IN THE AREA WHERE IT ATTACHES TO THE OPTICAL PART. THE DECISION WAS MADE TO LEAVE THE LENS WITH ONE INTACT HAPTIC IN THE PATIENT'S CAPSULAR BAG. NEXT DAY THE SURGEON RE-IMPLANTED THE IOL, REPLACED IT WITH UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18109194 ↗MalfunctionMay 9, 2023Crack; Crack
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE LENS WAS INSIDE THE EYE, THERE WAS A DEEP CRACK IN THE OPTICAL CENTER. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 16896428 ↗InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PHOTOPHOBIA AND CANT ADAPT TO IOL. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16136961 ↗MalfunctionNov 19, 2022Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE FIRST LENS WAS INJECTED WITH NO DIFFICULTY INTO THE EYE, NOTED A LINEAR CRACK NEAR THE CENTRE OF THE OPTIC AND REMOVED IT. OPENED THE SPARE LENS, HAD A QUICK LOOK UNDER THE MICROSCOPE BUT DIDN'T SEE ANY CRACK IN THE LENS (I HAVE TO SAY THAT I DIDN'T VIEW IT UNDER HIGH MAGNIFICATION). LOADING AND INJECTION OF LENS WAS EASY WITH NO ISSUE. ONCE AGAIN, SAW THE SAME LINEAR CRACK NEAR THE CENTRE OF THE OPTIC. DIDN'T HAVE ANY MORE LENS SO I LEFT IT IN THE EYE FOLLOWING A DISCUSSION WITH THE PATIENT. THERE WAS NO RESISTANCE WITH THE LATTER AND LENS WENT IN SMOOTHLY. I HAVE USED THE INJECTOR MANY TIMES IN THE PAST WITH NO ISSUE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED SATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15830896 ↗MalfunctionNov 19, 2022Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE FIRST LENS WAS INJECTED WITH NO DIFFICULTY INTO THE EYE, NOTED A LINEAR CRACK NEAR THE CENTRE OF THE OPTIC AND REMOVED IT. OPENED THE SPARE LENS, HAD A QUICK LOOK UNDER THE MICROSCOPE, BUT DIDN'T SEE ANY CRACK IN THE LENS (I HAVE TO SAY THAT I DIDN'T VIEW IT UNDER HIGH MAGNIFICATION). LOADING AND INJECTION OF LENS WAS EASY WITH NO ISSUE. ONCE AGAIN, SAW THE SAME LINEAR CRACK NEAR THE CENTRE OF THE OPTIC. DIDN'T HAVE ANY MORE LENS SO I LEFT IT IN THE EYE FOLLOWING A DISCUSSION WITH THE PATIENT. THERE WAS NO RESISTANCE WITH THE LATTER AND LENS WENT IN SMOOTHLY. I HAVE USED THE INJECTOR MANY TIMES IN THE PAST WITH NO ISSUE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED SATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15830864 ↗InjuryOct 17, 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 VISUAL ACUITY, PHOTOPHOBIA AND CANNOT ADAPT TO THE IOL. THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE FOR A MONOFOCAL INTRA OCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATED THAT PATIENT EXPERIENCED HALOS AND GLARE IN THE DAY TIME. THERE WAS NO PATIENT HARM AND THE ISSUE WAS RESOLVED. THE SURGEON PROGNOSIS WAS GOOD AND THE PATIENT WAS NOT HOSPITALIZED.
Patient problems: Halo; Visual Disturbances; Visual Impairment
MAUDE report 15619085 ↗InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED AFTER AN INTRAOCULAR LENS IMPLANT PROCEDURE, SMALL AMOUNT OF REFRACTIVE ERROR AND GLARE WAS OBSERVED, HENCE SUBSEQUENT LASER REFRACTIVE SURGERY WAS PERFORMED. THE PATIENT IS PUT INTO OBSERVATION AND MAY DECIDE FOR AN EXCHANGE IF REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED WHICH STATES UNABLE TO DRIVE AT NIGHT WITH HALOS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE LEFT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 15453554 ↗MalfunctionJul 27, 2022Crack; Crack
A PHYSICIAN REPORTED THAT DURING THE IMPLANTATION OF INTRAOCULAR LENS (IOL), LENS OPTIC CRACK. INITIALLY AFTER IMPLANTATION, THE PHYSICIAN THOUGHT AS FOLD BUT POST SURGERY CRACK CAN BE SEEN CLEARLY.
Patient problems: Insufficient Information
MAUDE report 15112939 ↗InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14082604 ↗MalfunctionApr 1, 2022Break; Break
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS BROKE WHEN INJECTING IT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13977568 ↗MalfunctionDec 23, 2021Scratched Material; Scratched Material
A SURGEON REPORTED THAT DURING AN CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS FOUND ON IOL OPTIC AFTER IMPLANTATION. SCRATCH WAS STILL THERE AFTER IRRIGATION AND ASPIRATION. THE SURGERY WAS COMPLETED WITHOUT IOL EXCHANGE. THE PATIENT HAD NOT CLAIMED ANY DECREASE IN THE SIGHT ABILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13072145 ↗InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED INTOLERABLE GLARE. THE IOL EXCHANGED FOR ANOTHER LENS NINETY-EIGHT DAYS FOLLOWING THE INITIAL PROCEDURE FOR A CLINICAL REASON OF HISTORY OF LASIK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 12606690 ↗InjurySep 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE IOL WAS LOADED AND INJECTED INTO THE CAPSULAR BAG A FISSURE WAS OBSERVED IN THE CENTRAL AREA OF THE LENS. THE IOL WAS REMOVED AND THE INCISION WAS ENLARGED. IN THE PROCESS THE HAPTIC ALSO RUPTURED. THE PROCEDURE WAS COMPLETED WITH THE SAME IOL MODEL AND POWER. ADDITIONAL INFORMATION WAS RECEIVED AND REPORTED THAT THERE WAS NO HARM TO THE PATIENT.
Patient problems: Eye Injury
MAUDE report 12487402 ↗MalfunctionJul 23, 2021Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12216709 ↗MalfunctionApr 27, 2021Device Damaged by Another Device; Scratched Material; Device Damaged by Another Device; Scratched Material
ADDITIONAL INFORMATION HAD BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS FOUND WHOLE BEFORE THE IMPLANT, AND SCRATCHED AFTER THE IMPLANT. THE PATIENT HAS NO IMPACT ON PATIENT'S VISUAL ACUITY DUE TO THE SCRATCH. BASED ON THIS INFORMATION THE CARTRIDGE IS CONSIDERED TO BE THE SUSPECT AND THE INTRAOCULAR LENS (IOL) IS NO LONGER A SUSPECT, HENCE THE FILE WILL BE NON-REPORTABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11731267 ↗InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A RIGHT EYE CATARACT PROCEDURE WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT REPORTED HALOS AND GLARE IN BOTH EYES. NIGHT DRIVING IS "EXTREMELY DIFFICULT."YAG LASER CAPSULOTOMY WAS PERFORMED. THE PATIENT RETURNED FOR A FOLLOW UP EVALUATION AND REPORTED "VERY UNCOMFORTABLE WITH THE HALOS, CANNOT LIVE WITH." THE PATIENT WISHES TO HAVE THE LENSES EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENTS LARGE PUPIL SIZE CONTRIBUTES TO THE REPORTED SYMPTOMS OF HALOS AND GLARE. TINTED GLASSES WERE PRESCRIBED FOR DRIVING BUT DEEMED INEFFECTIVE.
Patient problems: Dry Eye(s); Halo; Visual Disturbances
MAUDE report 11437287 ↗
Other Lens, multifocal intraocular devices
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- 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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