AcrySof™ IQ Vivity™ DFT015 (REF DFT015.175)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
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652421188), received between Apr 8, 2021 and Nov 21, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (1 report).
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 Problem3
- Crack1
- Scratched Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blurred Vision1
- Diplopia/Double Vision1
- Headache1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE PATIENT EXPERIENCED DOUBLE VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.
Patient problems: Diplopia/Double Vision
MAUDE report 23619915 ↗InjuryAug 22, 2025Adverse 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 WAS NOT SATISFIED WITH ALL RANGE OF VISION AND HAD HEADACHES AFTER IMPLANTATION SO SURGEON DECIDED TO EXTRACT THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Headache
MAUDE report 22873112 ↗InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT MANIFESTED REFRACTION. POST OPERATION IT WAS DETERMINED THAT THE PATIENT WOULD HAVE A BETTER OUTCOME WITH A 16.5 DIOPTER LENS. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE WITH A 16.5D LENS. THE PATIENT WAS MUCH HAPPIER AFTER REPLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Visual Impairment
MAUDE report 15173247 ↗MalfunctionJun 15, 2022Crack; Crack
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR IMPLANT SURGERY LENS FOUND TO BE CRACKED. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14695802 ↗MalfunctionApr 8, 2021Scratched Material; Scratched Material
A CUSTOMER REPORTED AN IMPLANTED INTRAOCULAR LENS (IOL) HAD A SCRATCH/DEFECT ON IT. THE LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11636196 ↗
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.