AcrySof™ IQ Vivity™ DFT015 (REF DFT015.185)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 Alcon AcrySof IQ Vivity lens is an artificial lens implanted in the eye after cataract surgery. Reports mostly describe blurry vision, especially up close, sometimes leading to the lens being removed and replaced, and lenses getting scratched, damaged or jammed during implantation. There are 25 reports that name its identifier, with no deaths and 14 injuries. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00380652421201), received between Mar 18, 2021 and Dec 26, 2025 — classified as 14 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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 Problem13
- Scratched Material4
- Defective Device2
- Material Split, Cut or Torn2
- Break1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Deliver1
Patient problems
- Blurred Vision8
- Insufficient Information6
- Visual Impairment6
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Visual Disturbances3
- Corneal Edema1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 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 EXPERIENCED NEAR-DISTANCE WAS NOT CLEAR. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY TWO MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Blurred Vision
MAUDE report 23896550 ↗InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY NEAR VISION. THE LENS WAS EXPLANTED AND REPLACED WITH COMPANY UNSPECIFIED MODEL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: Blurred Vision
MAUDE report 23888399 ↗MalfunctionAug 12, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS NOT EASY TO LOAD INTO THE CARTRIDGE AND UPON IMPLANTATION, THE LOWER HAPTIC DEPLOYED, JAMMING THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22784188 ↗MalfunctionApr 17, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE AT THE TIME OF LENS IMPLANTATION, THE LENS BECOMES TRAPPED, THE SURGERY WAS CONTINUED WITHOUT COMPLICATIONS WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21854814 ↗MalfunctionFeb 7, 2025Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS MISSING A HANDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21332073 ↗MalfunctionDec 26, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE SURGERY WAS COMPLETED WITH BACKUP LENS. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT CONTACT AND IT WAS NOTICED BEFORE THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019769 ↗MalfunctionNov 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR IMPLANT PROCEDURE THE LENS OPTIC WAS BROKEN. THE LENS WAS REMOVED AND IMPLANTED WITH SAME MODEL DURING THE INITIAL PROCEDURE. THERE WAS NO PATENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20682785 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THE LENS WAS EXPLANTED AND REPLACED WITH NON-COMPANY LENS.
Patient problems: Visual Impairment
MAUDE report 20156908 ↗MalfunctionApr 17, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A CENTRAL SCRATCH ON SIDE OF THE LENS. A LONG ATTEMPT WAS MADE TO REMOVE THE MARK WITH THE POLYMER IA (ASPIRATION IRRIGATION) TIP AND WAS NOT SUCCEEDED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19124013 ↗MalfunctionMar 25, 2024Failure to Unfold or Unwrap; Failure to Advance; Failure to Unfold or Unwrap; Failure to Advance
A NURSE REPORTED THAT AT THE TIME OF INTRAOCULAR LENS (IOL) INSERTION IN THE EYE, THE IOL UNFOLDED POORLY. THE SURGEON TOOK OFF THE IOL FROM THE EYE AND PLACED IT ONE MORE TIME CORRECTLY IN THE INJECTOR. HOWEVER, THE IOL AGAIN CAME OUT "FOLDED" FROM THE INJECTOR. DESPITE THE SURGEON'S MANIPULATIONS, THE IOL DID NOT SET UP PROPERLY. THUS, AFTER TWO NON-CONCLUSIVE INSERTIONS OF THE SAME IMPLANT (IOL), THE SURGEON DECIDED TO INSERT ANOTHER IOL IN SAME PROCEDURE, WHICH DEPLOYED NORMALLY FROM THE FIRST INSERTION. THERE WERE NO CLINICAL CONSEQUENCES WITNESSED AT THAT TIME, BUT THIS EVENT INCREASED THE RISK OF INFECTION AND INCREASED RISK OF POST-OPERATIVE COMPLICATIONS. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED. THE OPTIC GOT STUCK IN THE INJECTOR. THE BACKUP LENS USED FOR REPLACEMENT WAS OF SAME REFERENCE AND DIOPTER AS THAT OF ORIGINAL LENS. THERE WERE NO CLINICAL CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18968727 ↗MalfunctionSep 27, 2023Scratched Material; Scratched Material
A INVENTORY MANAGEMENT SPECIALIST REPORTED THAT DURING IMPLANTATION, SCRATCH WAS NOTICED IN THE MIDDLE OF THE INTRAOCULAR LENS (IOL). THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. IN SURGEON'S OPINION IT IS UNKNOWN IF THE IOL WAS DEFECTIVE, THE SCRATCH COULD POSSIBLY BE DUE TO LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17823527 ↗MalfunctionJun 21, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS NOTED AS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17172831 ↗MalfunctionMar 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS CAREFULLY INSERTED INTO INTRODUCER TAKING CARE NOT TO TOUCH OPTIC. THE WOUND NOTED TO BE SLIGHTLY TIGHT SO RATHER THAN FORCING NOZZLE INTO EYE, WOUND SLIGHTLY ENLARGED THEN NOZZLE INSERTED WITH EASE. AFTER IOL OPENED IN BAG, A SMALL SPLIT WAS NOTED IN THE CENTER OF THE LENS. THE DECISION MADE TO DO LENS EXCHANGE. SECOND SPARE COMPANY LENS USED AND INJECTED WITH EASE BENEATH INITIAL IOL INTO BAG AND SECURED. SPLIT LENS WAS THEN CUT WITH SCISSOR AND REMOVED IN TWO HALVES CAREFULLY FROM THE EYE. THERE WAS NO HARM TO PATIENT, POST OPERATION VISION 6/6 AT 3 WEEKS WITH 0.25 REFRACTION (AIM WAS PLANO). PATIENT DELIGHTED AND DUE FOR SECOND EYE LENS OPERATION.
Patient problems: Eye Injury; Insufficient Information
MAUDE report 16642264 ↗InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EPITHELIAL EDEMA AT THE 1,5/2-HOUR INCISION, OCP+1 (OCULAR CICATRICIAL PEMPHIGOID). THE PATIENT ALSO HAD VISION IMPAIRMENT AND VEL. THE DIAGNOSIS WAS MYOPIZATION, ASTIGMATISM INCREASE. THE SURGEON PRESCRIBED STEROIDS, ANTI-INFLAMMATORY DRUGS AND TREHALOSE. THE PATIENT HAD DECREASE IN VISUAL ACUITY (6/10) AFTER SEVERAL MONTHS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND UPDATED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Inflammation; Visual Impairment
MAUDE report 16580578 ↗InjuryJan 24, 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 EXPERIENCED SORE EYE AFTER SURGERY. THE SURGEON PRESCRIBED HIM THE EYE DROPS TO TREAT THE IRRITATION. THE EVENT HAS BEEN RESOLVED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Eye Pain
MAUDE report 16231944 ↗InjuryJun 20, 2022Fracture; Fracture
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN PLACING THE LENS AND PASSING IT THROUGH THE CARTRIDGE, IT FRACTURED AND CAUSED INCONVENIENCE TO THE DOCTOR. THE LENS WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE LENS WAS REMOVED BY MAKING A LARGER INCISION OF THE CORNEA. THE NEW LENS WAS IMPLANTED THE SAME DAY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14744685 ↗InjuryFeb 15, 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 EXPERIENCED SEVERE VISUAL DISCOMFORT, DISTORTION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENTS VISUAL SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 13534557 ↗InjuryJan 27, 2022Adverse 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 HAD HORRIBLE VISION AND WORSE THAN BEFORE SURGERY WITHOUT GLASSES. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT THE PATIENT IS COMPLETELY DEPENDING ON READING GLASSES TO SEE ANYTHING AT NEAR. HER DISTANCE VISUAL ACUITY IS OK, BUT NOT GREAT. SHE ALSO HAS SIGNIFICANT HALOS AND STREAKS IN HER RIGHT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 13367368 ↗InjuryDec 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED ABOUT GLARE. THE IOL EXCHANGE WAS PERFORMED IN SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 13093373 ↗InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND PROVIDED THAT PROVISC WAS USED FOR THE CASE. THE ADVERSE OUTCOME HAS RESOLVED AND THERE WERE NO PREDISPOSING FACTORS. ULTIMATELY THERE WAS NO HARM TO THE PATIENT.
Patient problems: Blurred Vision
MAUDE report 12987236 ↗InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGEON REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED REDUCED CONTRAST AT NEAR IN LOW LIGHT CONDITIONS COMPARED TO PRE OPERATION. PATIENT WAS USING MAGNIFYING GLASS FOR NEAR WORK IN LOW LIGHT, THE PATIENT ALSO STRUGGLED DRIVING AT NIGHT. ADDITIONAL INFORMATION WAS PROVIDED THAT THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL, IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 12780939 ↗MalfunctionOct 8, 2021Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT SCRATCHES WERE NOTICED ON THE INTRAOCULAR LENS (IOL) FOLLOWING IMPLANTATION. THE IOL WAS CUT, REMOVED AND A BACK-UP LENS WAS IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12600620 ↗InjuryJul 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED ABOUT NEAR VISION. THE IOL WAS EXCHANGED FOR A DIFFERENT MODEL IOL IN A SECONDARY PROCEDURE DUE TO THE PATIENT¿S DISSATISFACTION.
Patient problems: Blurred Vision
MAUDE report 12217789 ↗InjuryJun 16, 2021Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION RECEIVED STATING THE IOL WAS CENTERED IN THE EYE.
Patient problems: Visual Impairment
MAUDE report 12007918 ↗InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
INFORMATION WAS PROVIDED THAT COMPANY LENS WITH, 18.5 DIOPTER WAS REPLACED WITH A MONOFOCAL LENS. SURGEON ALSO INDICATED THAT THEY HAD SEEN SOME VITREOUS CLOUDING, WHICH MAY PARTLY EXPLAIN VISION ISSUE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Unspecified Eye / Vision Problem; Visual Impairment
MAUDE report 11516553 ↗
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.