AcrySof IQ PanOptix UV IOLRecalls & reported problems across all models
Alcon Laboratories, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 127
- Deaths reported
- 0
- Injuries reported
- 114
- Recalls
- 0
We found 28 models of AcrySof IQ PanOptix UV IOL by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 127 adverse event reports in the FDA's MAUDE database, received between Apr 28, 2022 and May 19, 2026 — classified as 114 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Defective Device” (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. 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 UV IOL problems
Device problems
- Adverse Event Without Identified Device or Use Problem105
- Defective Device4
- Device Dislodged or Dislocated4
- Scratched Material4
- Application Program Problem: Power Calculation Error1
- Break1
- Crack1
- Defective Component1
Patient problems
- Blurred Vision66
- Visual Disturbances50
- Visual Impairment44
- Halo27
- Insufficient Information13
- Vitreous Floaters7
- Dry Eye(s)6
- Eye Pain6
AcrySof IQ PanOptix UV IOL models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular18 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular14 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular12 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular7 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular7 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular6 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular5 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular4 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular3 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular2 reports
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
- AcrySof™ IQ PanOptix™ UV IOL TFAT00Lens, multifocal intraocular1 report
Recent AcrySof IQ PanOptix UV IOL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A TEAR IN THE POSTERIOR CAPSULE (PC). HOWEVER, THE SURGEON OPTED TO CONTINUE ON COURSE AND IMPLANT THE COMPANY IOL INTO THE SULCUS. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED UVEITIS GLAUCOMA HYPHEMA (UGH) SYNDROME DUE TO THE SINGLE PIECE IOL BEING IN THE SULCUS. THE IOL WAS EXCHANGED FOR UNSPECIFIED 3-PIECE MONOFOCAL IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN THE SURGEON¿S OPINION, PRODUCT DID NOT CAUSE THE EVENT, IT WAS THE LOCATION OF THE PRODUCT IN THE SULCUS THAT WAS THE ISSUE. IT WAS MENTIONED IF THERE WOULD NOT HAVE BEEN A PC TEAR/BAG BREAK, THIS WOULDN'T BE AN ISSUE, BUT THE SURGEON HAD NO CHOICE BUT TO PLACE IN SULCUS, THAT WAS THE ISSUE. THE LENS WAS EXCHANGED WITH NON-COMPANY LENS. THERE WAS NO FURTHER IMPACT TO THE PATIENT AND HEALING WELL WITH IOL IN GOOD POSITION.
Patient problems: UGH (Uveitis Glaucoma Hyphema) Syndrome
MAUDE report 25216001 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, SEVEN DAYS AFTER SURGERY, THE PATIENT DESCRIBED THEIR VISION WAS LOOKING LIKE THROUGH A SMUDGE OF VASELINE IN BOTH EYES. SO, THE PATIENT HAD LASER SURGERY. SURGEON SAID THAT THE PATIENT HAD AN OCCIPITAL GLIOMA. ADDITIONALLY, THE PATIENT UNDERWENT MANY NEURO STUDIES (NEUROLOGICAL MOTOR/SENSORY FINDINGS (MDS)) AND SCAN SHOWED NEGATIVE RESULTS (DID NOT HAVE OCCIPITAL GLIOMA OR EYE RELATED MULTIPLE SCLEROSIS). FURTHERMORE, ALL EYE EXAMINATION SHOWN NORMAL RESULTS AND THERE WAS NO EYE PAIN, BUT NOTHING WAS CLEAR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 24470362 ↗InjuryJun 20, 2025Adverse 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, THE PATIENT EXPERIENCED TROUBLE READING AND DIFFICULTY WITH BRIGHT LIGHT. THE IOL WAS EXCHANGED FOR A NON-COMPANY LENS 2 YEARS, 11 MONTHS, AND 5 DAYS AFTER THE INITIAL IMPLANT PROCEDURE, AND THE PATIENT WAS DOING WELL. SHE WAS HAPPY WITH THE RESULT AND WANTED TO MAKE NOTE THAT PEOPLE WITH MIGRAINES SHOULD NOT BE CONSIDERED CANDIDATES FOR MULTIFOCAL LENSES. THE PATIENT'S NEUROLOGIST HAD STATED, NEVER MESS WITH THE VISUAL STIMULATION OF A MIGRAINE SUFFERER.
Patient problems: Blurred Vision; Halo; Photophobia
MAUDE report 22302157 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS UNABLE TO ADAPT. CLINICAL REASON FOR EXPLANT WAS UNABLE TO ADAPT ON MULTIFOCAL INTRAOCULAR LENS (MF IOL). THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 04 MONTHS 25 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21943155 ↗InjuryApr 2, 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 BLURRY VISION, HALOS AND GLARE. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS BLURRY VISION, HALOS, GLARE AND NON ADAPTION OF THE LENS.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 21754920 ↗InjuryMar 7, 2025Adverse 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) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT COULD NOT ADAPT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED NON COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21549251 ↗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 ↗InjuryFeb 25, 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.
Patient problems: Blurred Vision
MAUDE report 21457605 ↗MalfunctionFeb 24, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS COMPLICATION WITH ADVANCEMENT OF LENS. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED BY USING SAME TYPE OF LENS. ADDITIONAL INFORMATION RECEIVE STATING THAT LENS DID NOT ADVANCE PROPERLY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447111 ↗InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT REASON WAS UNABLE TO ADAPT. THE IOL WAS REPLACED WITH MONOFOCAL LENS APPROXIMATELY SIX MONTHS AFTER INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Visual Impairment
MAUDE report 21422382 ↗InjuryDec 12, 2024Adverse 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) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS 1 MONTH FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION.
Patient problems: Blurred Vision
MAUDE report 20914187 ↗InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD GLARE. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL), 1 YEAR AND 7 MONTHS AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON WAS UNSATISFACTION WITH VISION AND GLARE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 20358434 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT FELT DIZZY EVERYDAY, EYE FATIGUE, CANNOT SEE PHONE OR ROAD SIGNS, VISION NOT BEING CLEAR, CONSTANT FOG IN LEFT EYE VISUAL ACUITY. YAG WAS DONE, LASIK WAS DONE, STILL NO IMPROVEMENT. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT WAS REPORTED AS SUBJECTIVE VISUAL DISTURBANCE. THERE WAS NO PATIENT HARM. SURGERY WENT WELL, HEALING WELL AT POD.
Patient problems: Blurred Vision; Dizziness; Visual Disturbances
MAUDE report 20266707 ↗InjurySep 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT PLANNED TO EXPLANT THE LENS DUE TO LENS TOUCHING THE IRIS. SHE STATES AT THE ORIGINAL SURGERY THE CAPSULE BROKE AND THE SURGEON IMPLANTED THE LENS OVER THE CAPSULE. SHE WAS SEEKING INFORMATION ON IF THE LENS CAN BE PRESERVED AND REPOSITIONED. ADDITIONAL INFORMATION WAS RECEIVED, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS. PATIENT VISION WAS DOING MUCH BETTER ALREADY AND THE EYE FEELS GOOD.
Patient problems: Capsular Bag Tear
MAUDE report 20198567 ↗InjuryJun 10, 2024Adverse 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) IMPLANT PROCEDURE, THE PATIENT WAS UNHAPPY WITH NEAR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS SLIGHT HYPEROPIC PRESCRIPTION FOLLOWING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE PATIENT'S VISION WAS OVERALL NOT CLEAR. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 19499123 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page