AcrySof IQ VivityRecalls & reported problems across all models
Alcon Laboratories, Inc. · 225 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,149
- Deaths reported
- 0
- Injuries reported
- 775
- Recalls
- 0
We found 225 models of AcrySof IQ Vivity by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 1,149 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and May 22, 2026 — classified as 775 injuries, 374 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (159 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 Vivity problems
Device problems
- Adverse Event Without Identified Device or Use Problem652
- Scratched Material159
- Defective Device65
- Device Dislodged or Dislocated47
- Break40
- Appropriate Device Problem Term/Code Not Available28
- Crack27
- Malposition of Device21
Patient problems
- Blurred Vision450
- Visual Impairment374
- Visual Disturbances231
- Insufficient Information202
- No Clinical Signs, Symptoms or Conditions191
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available100
- Halo55
- Dry Eye(s)31
AcrySof IQ Vivity models
225 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens44 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens37 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens34 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens33 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens29 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens27 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens25 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens25 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens23 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens21 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens21 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens20 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens20 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens19 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens19 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens18 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens18 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens18 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens16 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens16 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens15 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens15 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens13 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens12 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens12 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens11 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens11 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens11 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens11 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens10 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens10 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens10 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens9 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens9 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens9 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens9 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens8 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens8 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens8 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens8 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens8 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT415Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DAT415Extended depth of focus intraocular lens7 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens6 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens6 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens6 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens6 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens5 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT315Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT415Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DAT515Extended depth of focus intraocular lens4 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT015Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT315Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT415Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DFT515Extended depth of focus intraocular lens3 reports
- AcrySof™ IQ Vivity™ DAT015Extended depth of focus intraocular lens3 reports
Recent AcrySof IQ Vivity adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PATIENT VISION WAS VISION A WEEK AFTER THE OPERATION WAS 10/10 WITH SPH -0.75 BUT THE PATIENT MENTIONED THAT SHE HAD FOGGY VISION IN BOTH DISTANCES FAR AND NEAR. THE SURGEON SUGGESTED TO WAIT 2 WEEKS AND CHECK AGAIN THE VISION. POST OPERATIVE 3RD WEEKS THE PATIENT CONTINUED HAD THE SAME REFRACTION BUT SHE WAS STILL NOT HAPPY WITH THE VISION. THE PATIENT WAS MENTIONING A CLOUD FROM THE SIDE, LIKE THE EYE WAS OUT OF FOCUS. THE SURGEON DILATED THE PUPIL AND I FOUND A VERTICAL CRACK EXACTLY ON THE BORDERLINE OF THE ELEVATED PLATEAU OF THE LENS. ON THE (B)(6) 2026 THE SURGEON PERFORMED AN IOL EXCHANGE WITH IMPLANTATION OF A SINGLE PIECE LENS. 10 DAYS POSTOP THE VISION IS 10/10 AND THE PATIENT WAS HAPPY WITH HER VISION. THE SURGEON ASSESSED THAT CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT AS RELATED. THERE WAS NO IMPACT TO THE PATIENT. POST IOL EXCHANGE THE PATIENT HAD COMPLETELY RECOVERED. THERE WAS NO DELAY OCCUR DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PATIENT REPORTED DID NOT HAVE A GOOD VISION POST OPERATIVELY, DESCRIBING THE VISION A
Patient problems: Blurred Vision
MAUDE report 25255968 ↗MalfunctionMay 8, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS SCRATCHED IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25125449 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT DUE TO THE RESIDUAL ASTIGMATISM AND PATIENT INTOLERANCE, THE PATIENT EXPERIENCED HEADACHES AND WAS NOT ACHIEVING GOOD VISUAL ACUITY. AS A RESULT, THE LENS WAS EXCHANGED TO MONOFOCAL IOL WAS EXCHANGED FOR THE DIFFERENT LENS MODEL WITH SAME DIOPTER POWER INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE.
Patient problems: Headache; Insufficient Information; Visual Impairment
MAUDE report 25124138 ↗MalfunctionApr 16, 2026Dent in Material
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF LENS DAMAGED ON STRIPED OPTICS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WAS EXPLANTED DURING THE INITIAL PROCEDURE AND THE PATIENT CURRENT CONDITION WAS RECOVERED.
Patient problems: Insufficient Information
MAUDE report 24903232 ↗MalfunctionApr 9, 2026Device Damaged by Another Device
A PHARMACIST REPORTED THAT PLUNGER DID NOT PASS THROUGH THE INTRAOCULAR LENS (IOL) PROPERLY, RESULTING IN DAMAGE TO THE LENS. THE SURGERY WAS COMPLETED WITH A BACKUP LENS. THERE WAS NO PATIENT HARM. 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 24825534 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER ABOUT 5 MONTHS OF LENS IMPLANTATION THE OPHTHALMOLOGIST DECIDED TO PERFORM A CAPSULOTOMY FOR THE SO-CALLED SECONDARY CATARACT, AND THAT SAME EVENING, PATIENT BEGAN TO SEE EVERY LIGHT SOURCE WITH ENORMOUS AND ANNOYING RAYS. IT WAS EXPLAINED TO PATIENT THAT IT WAS DUE TO THE EDOF LENS, WHICH, IN COMBINATION WITH THE LASIK PROCEDURE, PRODUCED THIS EFFECT. PATIENT CAN ONLY SEE REASONABLY WELL IF PATIENT USED CHOLINERGIC AGONIST, WHICH CAUSED MYOSIS AND REDUCES THESE VERY ANNOYING EFFECTS, WHICH ALSO MAKE DRIVING DIFFICULT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 24772491 ↗MalfunctionMar 31, 2026Material Twisted/Bent
A NURSE REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PHYSICIAN NOTICED THAT THE HAPTIC WAS DAMAGED. THE SURGERY WAS NOT COMPLETED AND THE PATIENT WAS LEFT APHAKIC. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744344 ↗MalfunctionMar 18, 2026Material Opacification; Material Deformation
A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS HAD GLISTENING AND OPACIFICATION AND THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE PHYSICIAN HAS PLANNED TO EXPLANT THE LENS IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 24629600 ↗MalfunctionMar 16, 2026Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY IT WAS NOTICED THAT HAPTICS WAS SCRATCHED AND UNUSABLE. SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24604093 ↗InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PERSISTENT SYMPTOMS CONTINUED TO SIGNIFICANTLY IMPACT DAILY FUNCTIONING, AS WELL AS ABILITY TO WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Visual Disturbances
MAUDE report 24528200 ↗MalfunctionMar 3, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BEEN FAULTY AND COULD NOT BE USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24496305 ↗MalfunctionMar 2, 2026Failure to Unfold or Unwrap
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CANNOT FULLY EXPAND. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 24478970 ↗MalfunctionFeb 21, 2026Failure to Fold; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, IT WAS NOT POSSIBLE TO CORRECTLY IMPLANT THE LENS. THE ISSUE WAS RELATED TO THE IOL ITSELF, WHICH APPEARED EXTREMELY RIGID FROM THE BEGINNING AND BECAME STUCK INSIDE THE CARTRIDGE IMMEDIATELY. DUE TO THE RIGIDITY OF THE LENS, IT WAS NOT POSSIBLE TO EXTRACT IT OR REINSERT IT TO ATTEMPT A NEW IMPLANTATION. CONSEQUENTLY, A BACKUP LENS OF SAME MODEL BUT HALF A DIOPTER LESS POWER WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24408636 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE REASON FOR THE EXPLANT WAS PATIENT EXPRESSED DISSATISFACTION BECAUSE, DESPITE THE IMPLANTATION OF THE COMPANY LENS, SHE REPORTED INSUFFICIENT VISUAL ACUITY IN THE INTERMEDIATE AND NEAR VISION RANGES. SHE STATED THAT THE RESULT DID NOT MEET HER EXPECTATIONS AND THAT THIS SIGNIFICANTLY IMPAIRED HER QUALITY OF LIFE. SYMPTOMS WERE RESOLVED. THE LENS WAS EXPLANTED AND REPLACED WITH A NON-COMPANY LENS DURING SECONDARY PROCEDURE. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 24333638 ↗MalfunctionJan 30, 2026Product Quality Problem; Device Damaged by Another Device; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, IT WAS OBSERVED THAT THE LENS WAS FAULTY AND COULD NOT BE USED. ADDITIONAL INFORMATION RECEIVED STATING THAT THE DESPITE THE IOL BEING LOADED IN THE USUAL MANNER, THE LENS BECOME CRUMPLED AND ADVANCED FORWARD, MAKING IMPLANTATION IMPOSSIBLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24222923 ↗
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