AcrySof™ IQ Vivity™ DFT515 (REF DFT515.160)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652422383), received between Apr 10, 2023 and Oct 16, 2023 — classified as 2 injuries.
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 Problem2
Patient problems
- Visual Impairment2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 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 HAZY/CLOUDY VISION AND THERE WAS YAG, POSTERIOR CAPSULOTOMY, LASER VITREOLYSIS HAPPENED. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LIGHT ADJUSTABLE MONOFOCAL LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 17938873 ↗InjuryApr 10, 2023Adverse 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 VISION 6/9 PREOP, AND AT 2 MONTHS POST OPERATIVELY -0.50/-0.50, UCDVA 6/24, UCIVA/UCNVA J8. NO PATHOLOGY PO. THE OPTOMETRIST PRESCRIBED PROGRESSIVE GLASSES DUE TO NEED FOR BUS DRIVING (W +2.25ADD). ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT PATIENT HAS BEEN DISCHARGED TO THE OPTOMETRIST AND PROGRESSIVES WERE PRESCRIBED ACHIEVING 6/9+ VISION IN EACH EYE RESPECTIVELY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH LEFT EYE.
Patient problems: Visual Impairment
MAUDE report 16708376 ↗
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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.