AcrySof™ IQ Vivity™ DFT015 (REF DFT015.125)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV and Blue Light Filtering Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652421089), received between Aug 10, 2022 and Aug 21, 2024 — classified as 3 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 Problem3
Patient problems
- Blurred Vision2
- Corneal Edema1
- Halo1
- Retinal Tear1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A GOVERNMENT AGENCY REPORTED THAT A PATIENT UNDERWENT CATARACT SURGERY ON THE RIGHT EYE. THE PROCEDURE WAS PERFORMED UNDER REGIONAL ANESTHESIA. DURING SEDATION, REGURGITATION OCCURRED, CAUSING COUGHING. AFTER EXAMINATION, DESATURATION, A CHEST X-RAY WAS REQUESTED PRIOR TO SURGERY. THE RESULTS SHOWED NO PULMONARY FOCUS. PATIENT SEEN AGAIN AT NEXT DAY OF SURGERY, POSTOPERATIVE EXAMINATION WAS NORMAL. THE PATIENT WAS SEEN AGAIN AFTER ONE WEEK OF THE SURGERY, PRIOR TO SURGERY ON THE LEFT EYE, THE SURGEON NOTED THAT THE VISUAL ACUITY OF THE PATIENT'S RIGHT EYE WAS 1/20, AND THE REST OF THE CLINICAL EXAMINATION WAS NORMAL. THE PATIENT WAS IMMEDIATELY REFERRED TO A RETINAL SURGEON FOR ADVICE. THE DIAGNOSIS OF INTRA-RETINAL SCHISIS WAS THEN EVOKED. AN ANGIOGRAPHIC EXAMINATION WAS CARRIED OUT ON AND FOUND NO RETINAL PERFUSION ANOMALY. IN VIEW OF THE LACK OF IMPROVEMENT IN VISUAL ACUITY, IT WAS DECIDED TO CARRY OUT A CEREBRO-ORBITAL MRI AND HYPERBARIC OXYGEN THERAPY. PATIENT'S CURRENT CONDITION IS UNCHANGED.
Patient problems: Blurred Vision; Retinal Tear
MAUDE report 20016681 ↗InjuryApr 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED FOLLOWING THE INTRAOCULAR LENS IMPLANTATION THE PATIENT HAD EXPERIENCED BLURRY VISION AND POSITIVE DYSPHOTOPSIA. THE LENS WAS THEN EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH A MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PATIENT STILL HAD SYMPTOMS AT ONE WEEK POST OPERATIVE. IT COULD BE DUE TO GLAUCOMA DAMAGE.
Patient problems: Halo; Visual Disturbances
MAUDE report 16748638 ↗InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT, FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS HAVING INSUFFICIENT ACUITY AT NEAR. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Corneal Edema; Visual Impairment
MAUDE report 15202571 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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