AcrySof™ IQ Vivity™ DAT315 (REF DAT315.245)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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652427180), received between Oct 15, 2021 and Jun 7, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Physical Resistance/Sticking1
Patient problems
- Blurred Vision1
- Dry Eye(s)1
- No Clinical Signs, Symptoms or Conditions1
- Visual Disturbances1
- Visual Impairment1
- Vitreous Floaters1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DRY EYE SYNDROME, FLOATERS, AND EXTREME BLUR THAT THE PATIENT CANNOT DRIVE AT NIGHT AND CANNOT SEE WELL DURING THE DAY. THE PATIENT HAD A YAG CAPSULOTOMY BUT DID NOT IMPROVE VISION. HE HAS LOTS OF GLARE IN THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Blurred Vision; Dry Eye(s); Visual Disturbances; Visual Impairment; Vitreous Floaters
MAUDE report 19487666 ↗MalfunctionOct 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN IOL IMPLANT PROCEDURE THE LENS GOT CAUGHT ON THE WOUND WHILE BEING INJECTED AND GOT STUCK. THE SURGEON HAD TO CUT THE LENS OUT AND PUT A NEW ONE IN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639779 ↗
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- 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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