AcrySof™ IQ Vivity™ DFT015 (REF DFT015.215)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. The 37 reports mostly describe handling problems during implant surgery — lenses scratched, haptics (the little arms) twisted, torn or broken while loading the injector cartridge, or unfolding oddly — along with patient complaints of glare, blurry vision and other visual disturbance. 16 reports involved 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
- 37
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652421263), received between Mar 5, 2021 and May 8, 2026 — classified as 16 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (9 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 Problem14
- Scratched Material9
- Defective Device4
- Break3
- Defective Component2
- Device Contamination with Chemical or Other Material1
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information11
- Visual Impairment11
- Visual Disturbances7
- Blurred Vision6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Macular Edema1
- Nausea1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionNov 6, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC WAS TWISTED WHILE LOADING THE LENS INTO THE CARTRIDGE AND ABNORMAL POSITION OF THE HAPTIC WAS NOTICED WHEN IT WAS TAKEN OUT FROM THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER IOL. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE EVENT HAPPENED BEFORE IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485254 ↗MalfunctionNov 4, 2025Break; Break
A HEALTH PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS WERE TORN OFF DURING LOADING WAS A HANDLING ERROR. BACKUP PRODUCT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23472196 ↗MalfunctionOct 31, 2025Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE SCRATCHED LENS WAS REMOVED AFTER THEY IMPLANTED IT AND SAW THE SCRATCH ON THE LENS. THE SURGERY WAS COMPLETED BY REPLACING THE NEW LENS DURING THE SAME INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO HPATIC ISSUE REPORTED. THERE WAS NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438379 ↗InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AS THE PATIENT EXPRESSED DISSATISFACTION WITH HER LENSES DESPITE AN OBJECTIVELY SUCCESSFUL SURGICAL OUTCOME. OVER SEVERAL MONTHS, SHE CONTINUED TO REPORT SEVERE GLARE AND DYSPHOTOPSIA. DUE TO THESE PERSISTENT SYMPTOMS, THE LENSES WERE RECENTLY EXPLANTED AND REPLACED WITH LENSES FROM THE SAME MANUFACTURER BUT WITH A DIFFERENT DIOPTER. FOLLOWING THE REPLACEMENT, THERE HAVE BEEN NO FURTHER ADVERSE IMPACTS ON THE PATIENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Insufficient Information; Visual Disturbances
MAUDE report 23100877 ↗MalfunctionAug 1, 2025Inaccurate Delivery; Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS CAME OUT OF THE CARTRIDGE INCORRECTLY DURING INJECTION AND WAS NOT IMPLANTED. NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22686232 ↗MalfunctionJun 12, 2025Break; Break
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEGS OF THE LENS WERE BROKEN. THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22194986 ↗MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED PROBLEMS WITH THE UNFOLDING OF THE TWO HAPTICS OF THE LENS. LENS REMAINED IN THE EYE. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 21993657 ↗MalfunctionApr 4, 2025Scratched Material; Scratched Material
OTHER HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON NOTICED MARK OR SCRATCH ON LENS AFTER THE SURGEON IMPLANTED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773148 ↗MalfunctionMar 25, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE SURGEON NOTICED A SCRATCH ON THE LENS AFTER IOL INSERTION. THE LENS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 21686591 ↗MalfunctionMar 5, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS STUCK IN THE CARTRIDGE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21523535 ↗InjuryDec 27, 2024Adverse 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 HALOS AND STREAKS AT NIGHT, FUZZY VISION IN LOW LIGHT AND POOR DISTANCE VISION IN LEFT EYE THESE ISSUES WERE NOTED FROM THE BEGINNING. INITIALLY, THE HALOS AND STREAK MADE IT IMPOSSIBLE FOR THE PATIENT TO DRIVE AT NIGHT BUT NOW SHE CAN DRIVE BUT WITH SOME DIFFICULTY. THE SURGEON PRESCRIBED GLASSES FOR THE PATIENT, HOWEVER IT DID NOT EFFECTIVELY ADDRESS ANY OF THE ISSUES. THE GLASSES INDEED HELPED WITH THE CLOSE UP VISION AS THEY ARE BI-FOCAL. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 21025194 ↗MalfunctionNov 4, 2024Failure to Eject; Failure to Eject
A HEALTH PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE CARTRIDGE AND COULD NOT BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20600136 ↗InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,LENS WAS EXPLANTED AT INITIAL PROCEDURE DUE TO TEMPORAL HAPTICS CANNOT BE MOBILIZED.THE IOL WAS CUT IN THE MIDDLE AND REMOVED.THE TEMPORAL HAPTICS REMAINS IN THE CAPSULAR BAG AND DO NOT INTERFERE. SURGERY WAS COMPLETED WITH BACK UP LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED STATING FIBRIN-FIXED HAPTIC LEFT IN THE PERIPHERY. ADDITIONAL INFORMATION WAS RECEIVED STATING LENS WAS EXPLANTED AT SECONDARY PROCEDURE, WAS UNABLE TO COPE, AND SENSORY ADAPTATION PROBLEMS POSSIBLE.
Patient problems: Visual Impairment
MAUDE report 19984248 ↗MalfunctionJul 9, 2024Defective Component; Defective Device; Defective Component; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAPTIC BROKE OFF DURING LOADING INTO CARTRIDGE. LENS WAS NOT FLEXIBLE BUT HARD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19700588 ↗InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CORRECTION INFORMATION STATES LENS WAS NOT EXPLANTED.
Patient problems: Blurred Vision
MAUDE report 19346053 ↗InjuryDec 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT EXPERIENCED POOR VISION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MYOPIC SURPRISE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 18391942 ↗InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT PATIENT WAS IMPLANTED WITH AN INTRAOCULAR LENS (IOL) BUT PATIENT WAS UNHAPPY WITH VISION SINCE, THE PATIENT EXPERIENCED GLARE AND FUZZY VISION. POST-OP EVALUATION SHOWED A MYOPIC RESULT. YAG WAS ALSO DONE ON THIS EYE AND AT 6 MONTHS POST-OP THE PATIENT IS STILL MYOPIC,ALTHOUGH LAST REFRACTION WAS LESS THAN THE ONE OBTAINED RIGHT AFTER THE PROCEDURE.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 18203649 ↗InjuryOct 11, 2023Break; Break
A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS A BREAK IN THE HAPTIC DURING THE IMPLANTATION PROCESS, LEADING TO THE REMOVAL OF THE INITIAL INTRAOCULAR LENS AND SUBSEQUENT REPLACEMENT WITH A SECONDARY INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 17913096 ↗MalfunctionAug 3, 2023Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THAT THE LENS HAD SCRATCH ON OPTIC AREA. THE LENS WAS REMOVED AND EXCHANGED FOR ANOTHER IOL. SURGERY WAS SLIGHTLY DELAYED BUT CONCLUDED DURING INITIAL PROCEDURE WITH NO ADVERSE EFFECT OCCURRED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451568 ↗MalfunctionJul 30, 2023Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS, THE TRAILING HAPTIC STRETCHED. A SCRATCH ON THE OPTICS WERE NOTED AFTER IMPLANTATION. THE LENS WAS RETAINED IN EYE.
Patient problems: Insufficient Information
MAUDE report 17421595 ↗MalfunctionFeb 14, 2023Defective Device; Defective Device
A PHARMACIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEFECTIVE IOL WAS NOTED AND THE IOL WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16370070 ↗InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS EXPLANT DUE TO ASTIGMATISM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 15585109 ↗MalfunctionSep 20, 2022Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED, BUT INSPECTION UNDER THE MICROSCOPE REVEALED A SCRATCH. A LENS CHANGE WAS CARRIED OUT WITHOUT NEGATIVE EFFECTS ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15454408 ↗InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CONSUMER REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO TOLERATE LENS. HER GLARE WAS WORSE EVEN WITH INSIDE LIGHTING. ALL TESTING AND INTERVENTIONS DONE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT'S VISION IS STILL BLURRY.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15359608 ↗
Other Extended depth of focus intraocular lens devices
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- 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.