AcrySof™ IQ Vivity™ DAT015 (REF DAT015.110)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of AcrySof IQ Vivity (225)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00380652424455), received between Jan 13, 2022 and Apr 28, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision1
- 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.
MalfunctionApr 28, 2022Defective Device; Defective Device
A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A LENS WAS DEFECTIVE NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14233931 ↗MalfunctionJan 13, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
A NON HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S VISION WAS NOT CLEAR AND HAD UNDER CORRECTED VISION. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS TILT OR DECENTRATION WAS THE CAUSE FOR THE UNCLEAR VISION. THE LENS WAS EXPLANTED AND REPLACED 3 MONTHS FOLLOWING INITIAL PROCEDURE WITH ANOTHER TORIC IOL.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 13247714 ↗
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.
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