AcrySof™ IQ Vivity™ DAT515 (REF DAT515.165)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Toric Posterior Chamber Intraocular Lenses · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652428668), received between Jul 2, 2021 and Apr 29, 2022 — classified as 2 injuries, 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
- Adverse Event Without Identified Device or Use Problem1
- Defective Device1
- Device Contamination with Chemical or Other Material1
- Device Dislodged or Dislocated1
Patient problems
- Blurred Vision2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2022Defective Device; Defective Device
A NON-HEALTH PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE LENS FOUND TO BE DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 14254048 ↗InjuryFeb 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED WITHIN 3 MONTH AFTER IMPLANTATION DUE TO BLURRY VISION AND IOL DISLOCATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Blurred Vision
MAUDE report 13511903 ↗MalfunctionNov 17, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A SURGEON REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A FIBER WAS FOUND FIBER ON THE LENS. THE FIBER WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12829078 ↗InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON CUSTOMER REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS WAS IMPLANTED, THE PATIENT EXPERIENCED BLURRY VISION AT DISTANCE AND NEAR. THE PATIENT WAS UNHAPPY WITH VISION . THE LENS WAS EXCHANGED FOR A DIFFERENT LENS 4 MONTHS AFTER INITIAL IMPLANTATION. DYSPHOTOPSIA OF IOL WAS THE CLINICAL REASON GIVEN FOR THE EXPLANT. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Blurred Vision
MAUDE report 12106829 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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