Optovue Recalls Reference Materials Shipped with iVue and RTVue Systems
Optovue is recalling 795 units of reference materials shipped with iVue and RTVue systems because they were not included in the FDA clearance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when no specific injuries or hospitalizations are reported in the source text.
Plain-English summary
Optovue Inc. is recalling 795 units of reference materials, specifically the "RETINAL OCT Analysis and Interpretation Method" book and the "Retina" poster, which were shipped with iVue System (K091404) and RTVue Systems (K101505). The affected models are the iVue-100 and RTVue-100.
The recall was initiated because these specific reference materials were labeled for an intended use that was not included in the existing 510(k) or PMA clearance. The FDA classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
The affected units were distributed worldwide, including nationwide in the United States and internationally. Consumers and healthcare providers who have these specific reference materials should stop using them and contact Optovue Inc. for further instructions.
The recalled product
- Product
- Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by O
- Manufacturer
- Optovue Inc.
- Hazard
- Affected units
- 795
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All units of these models.
Distribution
Distributed nationwide across the United States.
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