Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Class I - DangerousWhat Should You Do?
- Check if you have this product: iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Optovue, Inc.
- Reason for Recall:
- Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version 3.0 (US) and 3.1(international) are different from those in the individual iWellness ID and OS reports.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.
Product Codes/Lot Numbers:
iVue software version 3.0 and 3.1 3.1 is international version, only distributed to Canada but not currently installed in any Canadian facilities.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1441-2013
Related Recalls
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).