AcrySof™ IQ Vivity™ DAT015 (REF DAT015.255)Recalls & reported problems
Alcon Laboratories, Inc. · Sterile UV Absorbing Acrylic Foldable Aspheric Wavefront-Shaping Posterior Chamber Intraocular Lens · Class 3 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652424745), received between Jul 19, 2022 and Aug 18, 2023 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Scratched Material1
Patient problems
- Blurred Vision2
- Insufficient Information1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD BLURRY DISTANCE VISION AND NEAR VISION WAS GOOD. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision
MAUDE report 17571955 ↗MalfunctionAug 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A CONSUMER REPORTED FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS, THE READING EYE LENS SHIFTS AND GETS FOGGY. THE CONSUMER HEARD SURGEON ASKED DURING SURGERY IF THE LENS THEY INSERTED WAS THE SMALLEST ONE THEY HAD. BUT WHEN SHE QUESTIONED THE SURGEON LATER, SHE WAS TOLD THERE WAS ONLY ONE SIZE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15291865 ↗MalfunctionJul 19, 2022Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A BLEMISH WAS OBSERVED. THE IOL WAS REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15049665 ↗
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- 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.