AcrySof™ IQ Vivity™ DAT315 (REF DAT315.140)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing 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
- 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 00380652426978), received between Jan 31, 2022 and Mar 16, 2023 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Blurred Vision2
- Visual Disturbances2
- Visual Impairment2
- Halo1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OPERATION ROOM MANAGER REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT WAS UNHAPPY WITH VIVITY LENS IN LEFT EYE AND WANTED IT REPLACED WITH A PANOPTIX. STATED VISION WAS NOT AS CLEAR IN THIS EYE (DESPITE PLANO MRX) AND NOTED A HALO AND DOUBLE IMAGE OUT OF THIS EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT EXPERIENCED BLURRED VISION, UNHAPPY WITH NEAR VISION, GLARE AND UNHAPPY WITH VISION QUALITY AT DISTANCE. PATIENT'S SYMPTOMS WERE RESOLVED.
Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment
MAUDE report 16551969 ↗InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION, ANISOMETROPIA AND MYOPIC SURPRISE. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL 4 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment
MAUDE report 13391487 ↗
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- 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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