AcrySof™ IQ Vivity™ DFT415 (REF DFT415.205)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
- 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 00380652422062), received between Jun 29, 2022 and Apr 17, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- Swelling/ Edema1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT AND CLINICAL REASON FOR EXPLANT WAS MENTIONED AS VISION OUTCOME. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 05 MONTHS 05 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 21854757 ↗InjuryJun 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE VISION HAS BEEN BLURRY FROM FIRST DAY. THE PATIENT CAN NOT USE OUT OF IT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING AS PER PATIENT, THE LENS IS NOT SEATED RIGHT, HER EYES ARE STILL BLURRY , HER PHYSICIAN TRIED TO CORRECT THE IOL POSITION , HOWEVER IT DIDN'T HELP AND HER EYES ARE STILL BLURRED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATED THAT EYE STILL HAVE SWELLING UNDER RIGHT EYE AS WELL AS RIGHT CHEEK.
Patient problems: Blurred Vision; Swelling/ Edema
MAUDE report 14853231 ↗
Other Extended depth of focus intraocular lens devices
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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.