AcrySof™ IQ Vivity™ DFT015 (REF DFT015.205)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
Quick summary
This AcrySof IQ Vivity lens is an implantable eye lens used in cataract surgery. Most of the 33 reports describe vision problems after surgery, such as blurred vision, glare from lights, and reduced eyesight; others describe handling issues during implantation, including scratches or marks on the lens, bent or broken parts, and the lens sticking in the injector. Reports mention 21 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00380652421249), received between Mar 25, 2021 and Apr 2, 2026 — classified as 21 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (6 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 Problem17
- Scratched Material6
- Defective Device2
- Material Opacification2
- Material Twisted/Bent2
- Break1
- Crack1
- Failure to Advance1
Patient problems
- Visual Disturbances12
- Blurred Vision9
- Visual Impairment8
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Halo2
- Inflammation2
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMay 6, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING INSERTED TRAILING HAPTIC WAS BROKEN.
Patient problems: Insufficient Information
MAUDE report 21968464 ↗MalfunctionApr 18, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED SCRATCH OR MARK ON OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21864989 ↗MalfunctionApr 18, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BENT HAPTIC. ADDITIONAL INFORMATION RECEIVED STATING THAT THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21863564 ↗MalfunctionFeb 3, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED WITH A DESCRIPTION, THERE WAS A PLACEMENT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Insufficient Information
MAUDE report 21289665 ↗MalfunctionJan 13, 2025Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED DURING SURGERY THAT THE INTRAOCULAR LENS (IOL) WAS STUCK IN INJECTOR IN TWO PLACES, THE PROXIMAL PART IS STUCK IN THE SNEMET AS WELL AS IN THE INJECTOR ITSELF. THERE WAS PATIENT CONTACT AND CATARACT PROCEDURE WAS COMPLETED WITH BACKUP LENS. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21139381 ↗InjuryNov 13, 2024Material Opacification; Material Opacification
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, MICRO-BUBBLES APPEARED ON THE SURFACE OF THE IMPLANT. THE PATIENT'S REFRACTION WAS IMPAIRED WITH FLICKERING AND THE IMPLANT WAS EXPLANTED AND RE-IMPLANTED WITH THE SAME LENS MODEL 29 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, INFLAMMATORY DEPOSIT ON IMPLANT WAS OBSERVED AFTER THE INITIAL IMPLANTATION OF IOL.
Patient problems: Inflammation; Visual Disturbances
MAUDE report 20675600 ↗MalfunctionOct 11, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT AN IOL WITH A SCRATCH DURING INJECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20425857 ↗MalfunctionFeb 12, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCHED CENTRAL OPTICS WAS NOTED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18685854 ↗InjuryDec 22, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE NOTICED A BLACK MARK ON THE LENS PLATE. THE SURGERY WAS COMPLETED WITHOUT REPLACEMENT. THE LENS WAS STILL IMPLANTED. THERE WAS NO PATIENT HARM BUT PATIENT HAD VISION PROBLEMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 18384142 ↗InjuryDec 12, 2023Material Opacification; Material Opacification
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRA-OCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED WHITE DEPOSITS IN THE IOL 8 WEEKS POST-OP. IOL LOOKED CLEAR WHEN IT WAS IMPLANTED. PATIENT HAD CORNEAL OEDEMA POST-OP, THE OEDEMA WAS CLEAR AT 8 WEEKS POST-OP WHICH ALLOWED THE SURGEON TO VIEW THE IOL OPTIC AND IT WAS AT THIS TIME THAT HE NOTICED THE WHITE DEPOSITS ON THE IOL. PATIENT COMPLAINED OF BLURRY VISUAL ACUITY AND FUZZY VISION. SURGEON PLANNING TO DO AN IOL EXCHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Corneal Edema
MAUDE report 18308679 ↗InjuryAug 22, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE LENS WAS EXPLANTED IN SECONDARY PROCEDURE. POST EXPLANTATION OF SEVEN DAYS PATIENT WAS SEEN AGAIN IN OUR PRACTICE WITH FINDING OF DESCEMET'S FOLDS AND IOL IN LOCO WITH VISUAL ACUITY 0.8.
Patient problems: Insufficient Information
MAUDE report 17595767 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING DAY OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD SEVERE INFLAMMATORY RESPONSE, EXUDATIVE MEMBRANE AROUND LENS WAS NOTICED, FUNDUS GLOW SEEN HAZY. NEXT DAY THE SYMPTOMS WORSENED FOR HAZE, FUNDUS WAS NOT SEEN, SEVERE EXUDATION AROUND LENS WAS NOTICED INSPITE OF STEROIDS AND CYCLOPLEGICS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE DIAGNOSIS AS VITREOUS INFLAMMATION AND THE PATIENT HAD CONJUNCTIVAL INFLAMMATION, AQUEOUS CELL +2, AQUEOUS FIBRIN PRESENT. THE PATIENT SYMPTOMS WERE IMPROVING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Conjunctivitis; Fibrosis; Inflammation
MAUDE report 17259651 ↗InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED. AFTER LENS IMPLANTATION, THE PATIENT HAD THREE SURGEONS LOOK AT THE LENS AND THEY ALL SAID THAT THE LENS WAS SCRATCHED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 16911530 ↗InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COULD NOT TOLERATE WITH THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS CONTRAST SENSITIVE. ADDITIONAL INFORMATION WAS RECEIVED AS ONE WEEK POST OPERATION, VITREOUS WAS IN ANTERIOR CHAMBER NOT PREVIOUSLY PRESENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Disturbances
MAUDE report 16895132 ↗InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAS NOT SEEN IT PROPERLY SINCE IT WAS PUT ON. THE DOCTOR SAYS THERE WAS NO PROBLEM IN THE SURGERY, BUT PATIENT CANNOT SEE WELL. THERE WAS DOUBLE VISION OR EVEN TRIPLE VISION. THE PATIENT CANNOT SEE THE FACE OF THE PERSON COMING 30 M IN THE SUNLESS CLOUDY WEATHER. THE PATIENT HAS A HARD TIME READING THE TEXTS ON TV FROM 3 METERS (DUE TO THE OVERLAPPING OF THE TEXTS). ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR RIGHT EYE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 16784214 ↗MalfunctionJan 2, 2023Crack; Crack
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON IMPLANTED THE LENS AND NOTICED A CRACK ON THE LENS. THE LENS WAS LEFT IN THE PATIENT'S EYE. THE PATIENT DID NOT NEED MEDICAL ATTENTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16082642 ↗InjurySep 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OPTOMETRIST REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISUAL ACUITY POST OPERATION, THE IOL WAS EXPLANTED AND REPLACED WITH MONOFOCAL INTRA OCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15462170 ↗InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION, GLARE AND HALOS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE SECOND EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances
MAUDE report 15130950 ↗InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED EYE PAIN/HURT ONE WEEK AGO AND READING VISION IS NOT WHAT WAS EXPECTED. THE PHYSICIAN PRESCRIBED ANTI INFLAMMATORY DRUGS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Eye Pain
MAUDE report 14053439 ↗MalfunctionMar 25, 2022Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED OF DEFECTIVE LENS.
Patient problems: Insufficient Information
MAUDE report 13899688 ↗InjuryMar 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT MYOPIC RESULTS AND PERFORMED YAG. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Visual Impairment
MAUDE report 13854926 ↗InjuryMar 21, 2022Adverse 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 HAS POST OPERATIVE SOME SICCA. THE PATIENT CANNOT WORK AND THAT IMAGE VIBRATES IN A LOT OF LIGHT POSSIBLY SCATTERED LIGHT DUE TO LONG TUNNEL INCISION. THE PATIENT PROBABLY SUFFERING FROM LENS INDUCED ABERRATIONS; CONSIDER LENS EXCHANGE. DURING SUBJECT MEASUREMENT, PATIENT INDICATED STILL SEEING A SHADOW IMAGE AFTER CYL CORRECTION. THE PHYSICIAN WAS NOT CONSIDERING A LENS CHANGE YET; WITH MONOFOCAL IOL, THIS PRE OP EMMETROPIC AND VERY CRITICAL / ANXIOUS PATIENT WONT BE HAPPY EITHER. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment
MAUDE report 13841528 ↗InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AND IRIS CHAFING. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Visual Impairment
MAUDE report 13636587 ↗InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLUR AND THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS REFRACTIVE MISS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13541228 ↗
Other Extended depth of focus intraocular lens devices
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens101 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens1 recall49 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens93 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens87 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens75 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens73 reports
- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens71 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.