AcrySof™ IQ Vivity™ DFT415 (REF DFT415.225)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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652422109), received between Jul 4, 2022 and Nov 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Failure to Eject1
- Failure to Unfold or Unwrap1
- Scratched Material1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2023Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18171142 ↗MalfunctionOct 17, 2022Device Damaged by Another Device; Failure to Eject; Device Damaged by Another Device; Failure to Eject
A NON HEALTHCARE PROFESSIONAL FROM PROCUREMENT DEPARTMENT REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, LENS DIDN¿T EJECT FROM THE CARTRIDGE PROPERLY AND DAMAGED THE LENS. THE SURGERY WAS COMPLETED WITH A BACK UP LENS.
Patient problems: Insufficient Information
MAUDE report 15613783 ↗MalfunctionJul 4, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS UNABLE TO UNFOLD ONCE IMPLANTED. THE LENS WAS REMOVED, RELOADED AND AGAIN IMPLANTED BUT THE ISSUE STILL REMAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE SURGERY WAS COMPLETED WITH ANOTHER LENS.
Patient problems: Insufficient Information
MAUDE report 14906491 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.