iVue iVue 100-1 (REF 700-47818-004)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K121739); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 27, 2017Terminated

   FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).

   Z-0008-2018 · Root cause: Other · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121739. One submission often covers many models, so check the product and lot details in each record.

• Z-1498-2016 · Mar 16, 2016 · Terminated
  iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomog
• Z-1441-2013 · May 14, 2013 · Terminated
  Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended for in vivo imaging.