AcrySof™ IQ Vivity™ DFT015 (REF DFT015.280)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
- 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 00380652421393), received between May 7, 2023 and Jul 17, 2025 — 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
- Blurred Vision2
- Visual Disturbances2
- Corneal Edema1
- Diplopia/Double Vision1
- Foreign Body Sensation in Eye1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, PATIENT¿S VISION WAS WORSE THAN BEFORE THE SURGERY AND CURRENTLY COULD NOT SEE WELL AT ANY DISTANCE. PATIENT¿S GOAL WAS TO GET RID OF GLASSES AND NOW NEED THEM MORE THAN BEFORE THE SURGERY. THE DOCTOR SAID THAT THE EYE-BRAIN WAS STILL ADAPTING, BUT PATIENT SEEMS THAT IT WAS TAKING TOO LONG. PATIENT¿S VISION WAS DOUBLE, THE IMAGE WAS SPREADING AND PATIENT HAD THE IMPRESSION THAT EYES STARTED TO SQUINT. PATIENT¿S VISION WAS TERRIBLE AT ANY DISTANCE, NO SHARPNESS, FOREIGN BODY SENSATION AND HAZE. PATIENT COULD NOT EVEN DRIVE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE IS FOR RIGHT EYE.
Patient problems: Blurred Vision; Corneal Edema; Diplopia/Double Vision; Foreign Body Sensation in Eye; Visual Disturbances
MAUDE report 22538902 ↗InjuryMay 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER BILATERAL IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD TROUBLE WITH GLARE AT NIGHT DRIVING, LETTERS WERE SLOPPY AND PATIENT SEE WELL UP CLOSE BUT SEE POORLY IN THE DISTANCE. THE PATIENT WAS PRESCRIBED WITH CORTICOSTEROID DROPS, A LOT OF TEARS DROPS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS 1 OF 2.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 16883717 ↗
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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.