AcrySof™ IQ Vivity™ DAT315 (REF DAT315.125)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 00380652426947), received between Feb 4, 2022 and Oct 4, 2022 — classified as 2 injuries.
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. 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
- Device Dislodged or Dislocated1
Patient problems
- Corneal Edema1
- Eye Injury1
- Inflammation1
- 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.
InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED BEST CORRECTED VISUAL ACUITY (BCVA). ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ON DAY 1 POST-OP, THE PATIENT EXPERIENCED VISION LIMITATIONS AND EDEMA/INFLAMMATION. THE PATIENT USES THE ANTIBIOTIC AND STEROID TREATMENT. ON POST OF DAY 7, THE PATIENT UNDERWENT A SUTURE REMOVAL PROCEDURE. ON POST OF 3 WEEKS VISIT PATIENT REPORTED FLOATER LOOKED LIKE FLY BUZZING AROUND AND DOES NOT SEE IT ANYMORE.
Patient problems: Corneal Edema; Eye Injury; Inflammation; Visual Impairment; Vitreous Floaters
MAUDE report 15538737 ↗InjuryFeb 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
A NURSE REPORTED FOLLOWING AN INTRAOCULAR LENS IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SHADOWS AROUND SUBJECTS DUE TO THE LENS DISLOCATED IN THE EYE. THE LENS WAS LATER EXCHANGED IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 13448939 ↗
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- 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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