AcrySof™ IQ Vivity™ DAT315 (REF DAT315.235)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652427166), received between Jul 12, 2021 and Apr 15, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 Problem2
- Scratched Material1
Patient problems
- Blurred Vision1
- Halo1
- Insufficient Information1
- Visual Impairment1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2024Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS SCRATCHED AFTER IMPLANTED. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH REPLACEMENT LENS.
Patient problems: Insufficient Information
MAUDE report 19104845 ↗InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSION REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT WAS NEVER ABLE TO SEE CORRECTLY. THE LENS WAS CAUSING THE PATIENT TO HAVE FOGGY EYESIGHT. THE LENS WAS EXCHANGED IN A SECONDARY PROCEDURE. POST LENS EXCHANGE PATIENT'S SYMPTOMS WERE RESOLVED.
Patient problems: Blurred Vision
MAUDE report 16059613 ↗InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE PATIENT EXPERIENCED HALOS AND DOUBLE VISION . THE LENS WAS EXCHANGED FOR MONOFOCAL LENS WITHIN TWO MONTHS AFTER INITIAL IMPLANTATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Halo; Visual Impairment
MAUDE report 12148948 ↗
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- 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.