AcrySof™ IQ Vivity™ DFT515 (REF DFT515.195)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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652422451), received between Aug 10, 2022 and Jun 27, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective 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.
Most reported problems
Device problems
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- Discomfort1
- Dry Eye(s)1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2023Defective Device; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT LENS NOT IMPLANTED DUE TO DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17207706 ↗MalfunctionAug 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A HEALTH PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED RESIDUAL REFRACTIVE ERROR DUE TO LENS HAS SHIFTED TO 5 DEGREES INSTEAD OF 174 DEGREES. PATIENT FEELS DISCOMFORT WHEN TOUCHES HER EYE AT NOON AND EVEN WHEN SHE DOES NOT TOUCH THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Discomfort; Dry Eye(s); Visual Impairment
MAUDE report 15199404 ↗
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- 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.