AcrySof™ IQ Vivity™ DFT015 (REF DFT015.200)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. The 23 reports mostly describe blurred vision, halos and disappointing vision results, often with lenses found scratched, cracked or marked during or after surgery, sometimes needing removal and replacement. The reports mention no deaths and 12 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
- 23
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380652421232), received between Jul 12, 2021 and Oct 23, 2024 — classified as 12 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (3 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 Problem8
- Scratched Material3
- Crack2
- Defective Device2
- Application Program Problem: Power Calculation Error1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Defective Component1
Patient problems
- Visual Impairment8
- Insufficient Information7
- Blurred Vision6
- No Clinical Signs, Symptoms or Conditions3
- Visual Disturbances3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Halo2
- Headache2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT HAD DID NOT MEET VISION SATISFACTION OUTCOME. CLINICAL REASON BEING MENTIONED AS NOT MET DESIRED PO (POST OPERATION) REFRACTION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20515170 ↗MalfunctionOct 11, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20426485 ↗MalfunctionApr 2, 2024Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION DEFECT ON THE SURFACE OF THE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19024141 ↗MalfunctionFeb 16, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, ALONG POST-OP EXAMINATION THE DAY AFTER THE SURGERY, MARKS ON THE IOL ARE VISIBLE WITH THE SLIT LAMP. THE SALES REPRESENTATIVE ADDS THAT THE IMPLANT WAS PLACED IN COMPLIANCE WITH THE PROTOCOL AND AT THE END OF THE SURGERY THERE WERE NO MARKS ON THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE NEXT POST-OPERATIVE CHECK-UP WAS SCHEDULED IN FEW DAYS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THE SURGEON INDICATED THAT THE IOL HAD NO MARKS PRE-OPERATIVELY AND APPEARED AT THE SLIT LAMP ON D+1. THE MARKS ARE ON THE VISUAL AXIS BUT THE PATIENT IS NOT BOTHERED VISUALLY. NO CLINICAL CONSEQUENCES, NO EXPLANTATION PLANNED, THE PATIENT HAS A GOOD VISUAL ACUITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18720656 ↗MalfunctionFeb 8, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS DIDN¿T RELEASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18667247 ↗MalfunctionDec 26, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING BASED ON PHYSICIAN'S OPINION, THE OPERATED EYE WOULD NOT SUFFER ANY PERMANENT DAMAGE AS A RESULT OF THE IOL REMOVAL AND SECONDARY IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 18391945 ↗InjuryNov 17, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT LENS HAD GLISTENINGS. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN RECEIVED INCLUDES PATIENT HAD FEMTO LASER SURGERY ON BOTH EYES. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18160848 ↗MalfunctionOct 16, 2023Crack; Crack
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS HAD CRACK ON THE OPTIC. THIS WAS ONLY NOTICED AFTER THE LENS WAS IMPLANTED INTO THE EYE. SURGEON DECIDED TO LEAVE THE LENS INSIDE THE EYE BECAUSE THE DEFECT WAS OUTSIDE OF VISUAL AXIS.
Patient problems: Insufficient Information
MAUDE report 17938691 ↗InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED AS AN INTRAOCULAR LENS REPLACEMENT PROCEDURE WAS CONDUCTED, AND A MONOFOCAL LENS WAS UTILIZED. THE PRIMARY REASON FOR THE EXPLANTATION WAS THE PATIENT'S EXPERIENCE OF HALOS FOLLOWING THE IMPLANTATION. FURTHERMORE, THE REFRACTIVE OUTCOME DID NOT ALIGN AS ANTICIPATED.
Patient problems: Halo; Insufficient Information; Visual Impairment
MAUDE report 17378629 ↗MalfunctionJun 6, 2023Material Opacification; Material Opacification
A NON-HEALTH CARE PROFESSIONAL REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED RING AROUND THE SOURCE OF LIGHT AT NIGHT AND HAD A PIERCING SENSE AND HEAVINESS IN THE EYE. THE PATIENT WAS UNABLE TO KEEP THE EYE OPEN CONTINUOUSLY AND SOMETIME LOSES VISION FOR THE FRACTION OF TIME. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT HAD EXPERIENCED HEADACHE AND FELT SOMETHING WAS PREVENTING THE VISION LIKE A MEMBRANE IN THE EYE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THE PHYSICIAN HAVE ASSURED NO FOREIGN PARTICLE IN THE EYE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache; Irritability; Visual Disturbances; Visual Impairment
MAUDE report 17072239 ↗MalfunctionMay 5, 2023Use of Device Problem
DEAR SIR I HAVE CATARACT SURGERY AS ON (B)(6) 2023. DOCTOR OF (B)(6) HAS PLACED ACRYSOF IQ VIVITY IOL SN (B)(6. AFTER SURGERY I HAVE GOT THE FOLLOWING COMPLICATIONS- 1 RING AROUND THE SOURCE OF LIGHT IN NIGHT EVEN THOUGH COMPANY CLAIM THERE RING SHOULD NOT IN CASE OF IOL LENSES. 2. HEADACHE 3. HEAVINESS SURROUNDING THE EYE. 4.FEELING SOMETHING PREVENTING VISION LIKE A MEMBRANE. 3 UNABLE TO OPEN EYE CONTINUOUSLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Sensation in Eye; Halo; Headache
MAUDE report 16888031 ↗InjuryDec 1, 2022Break; Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT PROCEDURE, THE LENS FOUND TO BE CRACKED 2/3 OF THE LENS. NOTICED DURING IOL IMPLANTATION WHILE UNFOLDING IN EYE. THE IOL WAS EXPLANTED FROM THE PATIENT AND BACK UP LENS WAS IMPLANTED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, LEFT EYE WAS MORE PAINFUL POST OP AS SURGEON HAD TO ENLARGE WOUND TO REMOVE AND REPLACE LENS. THIS ALSO CAUSES INCREASED ASTIGMATISM SO THE VISION IS NOT AS CLEAR BUT HOPEFULLY THIS WILL CORRECT WHEN I REMOVE SUTURE IN SIX WEEKS.
Patient problems: Eye Injury; Eye Pain; Visual Disturbances
MAUDE report 15891780 ↗MalfunctionNov 21, 2022Defective Component; Device Dislodged or Dislocated; Defective Component; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A HAPTIC ELEMENT OF THE IOL WAS DAMAGED. THE QUALITY OF VISION HAS BEEN REDUCED BECAUSE OF THE INCORRECT CENTRATION OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 15833688 ↗MalfunctionNov 16, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT DOES NOT EXPAND IN THE EYE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, IOL DID NOT UNFOLD IN THE LEFT EYE (OS), IT DID TOUCH THE EYE. THE SURGEON COMPLETED THE SURGERY WITH ANOTHER IOL. THERE WAS NO PROBLEM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15803654 ↗InjuryNov 1, 2022Adverse 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 COMPLAINED ABOUT NOT HAVING A QUALITY OF VISION. HE STATED THAT IT GOT MUCH WORSE AFTER THE SURGERY, AND HE PRACTICALLY CANNOT SEE IF HE COVERS THE EYE THAT WAS NOT OPERATED ON. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 15709894 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGICAL TECHNICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND MYOPIA. THE IOL EXCHANGED FOR ANOTHER LENS 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WILL BE REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15698255 ↗MalfunctionAug 4, 2022Scratched Material; Scratched Material
A NURSE REPORTED THAT AFTER IMPLANTATION OF AN INTRAOCULAR LENS (IOL), HE NOTICED A WHITE LINE ON THE SIDE OF THE LENS. AS IT DID NOT AFFECT THE CENTRAL OPTIC HE DECIDED TO LEAVE IT IN THE PATIENTS.
Patient problems: Insufficient Information
MAUDE report 15164972 ↗InjuryJul 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT COULD NOT SEE DISTANCE AND NO MORE VISION NEAR EVEN WITH CORRECTION. IN SURGEON'S OPINION, THE LENS DID CONTRIBUTE TO EVENT. THE LENS WAS EXCHANGED WITH NON COMPANY LENS IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Blurred Vision
MAUDE report 14906857 ↗InjuryJun 14, 2022Application Program Problem: Power Calculation Error; Application Program Problem: Power Calculation Error
A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED DISTANCE VISION. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 7 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS INCORRECT IOL POWER CALCULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 14684916 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED UNINTENDED MYOPIA/CANNOT SEE DISTANCE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 14315788 ↗InjuryMar 22, 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 HAD REALLY BAD VISION. ADDITIONAL INFORMATION RECEIVED STATED THAT 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 RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Dry Eye(s); Visual Disturbances; Visual Impairment
MAUDE report 13854980 ↗InjuryAug 16, 2021Crack; Crack
A PHYSICIAN REPORTED THAT DURING SURGERY LENS CRACK WAS FOUND AFTER IMPLANT. THE PATIENT COMPLAINED HIS VISION BLURRY, SO THE LENS WAS EXCHANGED LATER. NO OTHER INFORMATION AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 12325175 ↗InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROVIDER REPORTED EXPLANTATION OF AN INTRAOCULAR LENS (IOL) DUE TO A "LARGE HYPEROPIC OUTCOME, NOT CORRECTABLE WITH LASER AND POOR VISION." THE IOL WAS EXCHANGED WITH AN ALTERNATE LENS APPROXIMATELY 2 1/2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: Visual Impairment
MAUDE report 12149054 ↗
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- TECNIS IOL ZXR00Johnson & Johnson Surgical Vision, Inc. · Extended depth of focus intraocular lens89 reports
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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
- 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.