AcrySof™ IQ Vivity™ DFT515 (REF DFT515.235)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
All models of AcrySof IQ Vivity (225)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652422536), received between Jun 1, 2021 and Jun 1, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Capsular Bag Tear1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 1, 2021Malposition of Device; Malposition of Device
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL BECAME DISLOCATED. THE IOL WAS REMOVED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS PROVIDED BY THE SURGEON THAT THE POSTERIOR CAPSULE APPEARED INTACT PRIOR TO INSERTING THE LENS, WHEN ROTATING THE LENS, A POSTERIOR TEAR WAS NOTED AND THE LENS FELL IN TO THE VITREOUS. THE EYE WAS CLOSED AND THE PATIENT WAS SENT TO A RETINA SPECIALIST FOR EVALUATION THE SAME DAY. THE IOL WAS EXCHANGED THE NEXT DAY. IN THE SURGEON'S OPINION, THE IOL DID NOT CAUSE THE EVENT. THE EVENT WAS CAUSED BY THE POSTERIOR CAPSULAR TEAR. THERE WAS NO PATIENT HARM, THE PATIENT'S ISSUES HAVE RESOLVED AND THE PROGNOSIS IS GOOD. THERE IS A MILD RESOLVING VITREOUS HEMORRHAGE.
Patient problems: Capsular Bag Tear
MAUDE report 11915146 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page