AcrySof™ IQ Vivity™ DAT315 (REF DAT315.155)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 00380652427005), received between Dec 16, 2021 and Nov 8, 2022 — 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
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Edema1
- Headache1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED BEST CORRECTED VISUAL ACUITY (BCVA). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ON POST-OP DAY 1, THE PATIENT EXPERIENCED VISION LIMITED BY EDEMA AND INFLAMMATION AND USED ANTIBIOTIC AND STEROID MEDICATION. ONE WEEK LATER, THE POST-OP PATIENT WAS DOING WELL AND FINISHED WITH ANTIBIOTIC STEROID MEDICATION, BUT EXPERIENCED MIGRAINES.
Patient problems: Corneal Edema; Headache; Inflammation; Visual Impairment
MAUDE report 15752801 ↗InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED EYE STRAIN FOR NEAR VISION AND INSUFFICIENT NEAR VISION. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE 29 DAYS FOLLOWING THE INITIAL PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision
MAUDE report 13022954 ↗
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 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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