AcrySof™ IQ Vivity™ DFT015 (REF DFT015.195)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00380652421225), received between Apr 2, 2021 and Feb 7, 2025 — classified as 13 injuries, 6 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 Problem10
- Scratched Material4
- Defective Device2
- Device Damaged by Another Device1
- Device Dislodged or Dislocated1
- Difficult to Fold, Unfold or Collapse1
- Failure to Advance1
Patient problems
- Blurred Vision6
- Insufficient Information5
- Visual Impairment5
- Visual Disturbances3
- Capsular Bag Tear2
- Capsular Contracture1
- Flashers1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON NOTICED A CAPSULAR RUPTURE, WHICH MADE THIS CHOICE OF IMPLANT IMPOSSIBLE. THE SURGEON ALSO STATED THAT HE HAD CONCERNS ABOUT THE DESTERILIZATION OF THE INITIAL IMPLANT. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE AND REPLACED WITH A THREE-PIECE INTRAOCULAR LENS. THE OPERATION ENDED WITH AN ANTERIOR VITRECTOMY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 21331678 ↗MalfunctionOct 3, 2024Scratched Material; Scratched Material
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING IT WAS DIFFICULT FOR THEM TO VERIFY THAT IT WAS THE CORRECT IOL AS IT HAD BEEN CUT FOR REMOVAL.
Patient problems: Insufficient Information
MAUDE report 20357439 ↗MalfunctionMay 8, 2024Scratched Material; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS WAS SCRATCHED DURING IMPLANTATION, NOT SURE IF THIS HAPPENED DURING LOADING PROCESS. DAMAGED LENS WAS TAKEN OUT FROM THE EYE AND NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE DEVICE WAS PREPPED FOR LOADING AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19268814 ↗InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT WAS HAVING NO COMPLAINTS AND THE EXPLANTATION OF THE LENSES WAS NOT NECESSARY.
Patient problems: Capsular Contracture
MAUDE report 18204768 ↗MalfunctionOct 16, 2023Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IOL (INTRAOCULAR LENS) WAS STUCK IN THE CARTRIDGE AND WAS NOT EJECTING. THERE WAS NO PATIENT HARM AND THE SURGERY WAS COMPLETED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17938321 ↗InjurySep 12, 2023Adverse 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 CORRECTED VISUAL ACUITY (CVA) WAS DECREASED FROM 0.6 TO 0.3 AND 9 MONTHS AFTER THE SURGERY THE PATIENT'S UNCORRECTED VISUAL ACUITY (UCVA) WAS 0.15. THERE WAS NO IMPROVEMENT IN DISTANCE OR NEAR VISION. YAG LASER TREATMENT WAS NOT PERFORMED. DOCTOR WANTS TO WAIT AND SEE IF THE PATIENT'S VISION WILL IMPROVE WITH TIME FOR IOL EXCHANGE. BUT THE VISION WAS NOT IMPROVED AND IOL WAS EXPLANTED AND EXCHANGED WITH NON COMPANY LENS 1 YEAR 5 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17728888 ↗InjuryApr 6, 2023Adverse 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 EXPERIENCED SHADOWS/ BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AFTER APPROXIMATELY EIGHT MONTHS OF INITIAL IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16688521 ↗InjuryMar 27, 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 EXPERIENCED POOR VISION AT DISTANCE AND NEAR. THE LENS WAS EXPLANTED AND REPLACED WITH OTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS DYSPHOTOPSIA . ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 16618693 ↗InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A SURGEON REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SEES THE HEADLIGHTS OF THE CAR IN A LONGITUDINAL OVAL SHAPE AND THREE MORE SHADOWS AROUND IT, THE FIRST ONE IS BLACK, OUTSIDE OF IT IS RED, AND THEN WHITE. THE SURGERY WENT WITHOUT COMPLICATIONS, THE PSEUDOPHAKIA IS NORMAL, THE MACULAR OCT (OPTICAL COHERENCE TOMOGRAPHY) WAS REPEATED POSTOPERATIVELY AND THE FINDINGS WAS NORMAL. THE YAG (YTTRIUM ALUMINUM GARNET) LASER CAPSULOTOMY WAS PERFORMED ON THE LEFT EYE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 15486212 ↗MalfunctionJul 27, 2022Difficult to Fold, Unfold or Collapse; Scratched Material; Difficult to Fold, Unfold or Collapse; Scratched Material
THE SURGEON REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HE NOTICED THAT THE IMPLANT WAS MARKED IN ITS CENTER BECAUSE OF THE PISTON OF OUR INJECTOR (NO POSSIBILITY FOR THE SURGEON TO TAKE A PICTURE WITH A SLIT LAMP). THE SURGEON DID NOT SUCCEED IN FOLDING THE IMPLANT ON THE FIRST TRY DURING THE PROCEDURE. HE ALSO REPORTED ABOUT POOR RESULTS AFTER THE IOL IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED THAT, THE MARK IN THE CENTER OF THE IMPLANT NOTED IN THE VISUAL AXIS, DURING ONE MONTH POST OP CONSULTATION.
Patient problems: Blurred Vision
MAUDE report 15111316 ↗MalfunctionMay 7, 2022Device Damaged by Another Device; Device Damaged by Another Device
A NURSE REPORTED LENS WAS DAMAGED IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14317191 ↗InjuryMay 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD DIFFICULTY IN SEEING NEAR AND DISTANCE. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS FOR LEFT EYE.
Patient problems: Blurred Vision
MAUDE report 14314237 ↗InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS INCOMPATIBLE WITH THE IOL. FIRST THE IOL HAD A MINIMAL TILT AND THE PATIENT VISUAL ACUITY WAS 20/32. AFTER ROTATION THE VISUAL ACUITY GET WORSE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE IS NO PATIENT HARM AND THE VISUAL ACUITY IS RECOVERED NOW. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT VISUAL ACUITY WAS FOUND AT 0.4 DECIMAL (20/50) WHICH WAS FOUND ON (B)(6) 2022. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 13952083 ↗MalfunctionMar 28, 2022Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13926373 ↗InjuryNov 16, 2021Scratched Material; Scratched Material
A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS FOUND ON THE OPTIC SO THAT THE IOL WAS REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 12821190 ↗InjuryOct 26, 2021Adverse 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 WAS UNHAPPY WITH VISUAL ACUITY. THE IOL EXCHANGED FOR ANOTHER LENS FORTY TWO DAYS FOLLOWING THE INITIAL PROCEDURE FOR CLINICAL REASON OF UNDER CORRECTION OF ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 12698160 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE IOL WAS EXCHANGED WITH ANOTHER DIFFERENT MODEL IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision; Flashers; Visual Impairment
MAUDE report 12376301 ↗InjuryJul 9, 2021Adverse 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, THE PATIENT EXPERIENCED DISTANCE AND NEAR BLURRY VISION WITH NO IMPROVEMENT IN VISION. THE IOL WAS EXCHANGED WITH AN ALTERNATE IOL APPROXIMATELY 2 MONTHS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 12145545 ↗InjuryApr 2, 2021Defective Device; Defective Device
ADDITIONAL INFORMATION WAS PROVIDED THAT THERE WAS NO PATIENT HARM AND THE PATIENT'S ISSUES HAVE RESOLVED.
Patient problems: Capsular Bag Tear; Visual Impairment
MAUDE report 11608360 ↗
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.