AcrySof™ IQ Vivity™ DFT015 (REF DFT015.130)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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652421096), received between Aug 4, 2022 and Oct 24, 2023 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (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 Problem1
- Break1
- Defective Device1
- Failure to Eject1
Patient problems
- Insufficient Information2
- Blurred Vision1
- Capsular Bag Tear1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2023Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED IN THE SURGEON¿S OPINION IMPROPER LENS LOADING WAS THE CAUSE OF THE EVENT. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 17996588 ↗MalfunctionApr 20, 2023Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO BE DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16776634 ↗MalfunctionMar 31, 2023Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR HAD PUT A LENS INTO A PATIENT'S EYE WHEN THE LENS FRAGMENTED AND BROKE INTO SMALL PIECES, THEN SHE MANAGED TO REMOVE ALL THE PIECES. ADDITIONAL INFORMATION WAS RECEIVED STATING POSTERIOR CAPSULAR RUPTURE AFTER LENS INSERTION (BAG BLEW OPEN WITH ATTEMPTED VISCOELASTIC REMOVAL VIA IRRIGATION AND ASPIRATION). AS PER SURGEON¿S OPINION, PRODUCT DID NOT CONTRIBUTE TO THE EVENT. SURGERY WAS COMPLETED WITH 3-PIECE SULCUS LENS AFTER THE FIRST LENS WAS REMOVED FROM THE EYE (REMOVED BY CUTTING IT INTO 3 SEGMENTS USING CUTTERS). PATIENT'S SYMPTOMS WERE RESOLVED. PATIENT WAS DOING VERY WELL WITH MULTIPIECE LENS. THERE WAS NO PATIENT HARM.
Patient problems: Capsular Bag Tear
MAUDE report 16653991 ↗InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT IS POOR VISUAL QUALITY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 15162118 ↗
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- 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.