AcrySof™ IQ Vivity™ DAT315 (REF DAT315.115)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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380652426923), received between Nov 30, 2022 and Nov 30, 2022 — classified as 1 injury.
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 Problem1
Patient problems
- Dizziness1
- Excessive Tear Production1
- Flashers1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT MINIMAL VISION IMPROVEMENT AND MULTIPLE VISION ISSUES. THE PATIENT EXPERIENCED FLASHING LIGHTS/ ROTATING PRISM WHITE LIGHT, WAS CONSTANTLY PINCHING WITH EVERY BLINK. HAD DEPTH PERCEPTION, DIZZY AND EXCESSIVE TEARING. THE PATIENT ASTIGMATISM WAS JUST NOT CORRECTABLE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PHYSICIAN SUGGESTED ARTIFICIAL TEARS AND THAT HELPS. SYMPTOMS WERE CONTINUING.
Patient problems: Dizziness; Excessive Tear Production; Flashers; Visual Disturbances; Visual Impairment
MAUDE report 15887324 ↗
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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