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Optovue, Inc.

Complete recall history across all FDA and CPSC categories — 5 total recalls

Optovue, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (5)

FDA medical device enforcement actions by Optovue, Inc.

Date Product Reason Class
Jul 27, 2017 iVue 500 with iScan, D216606. Product non-contact, high resolution tomogr... FDA determined that a 510(k) is needed for the Vault Mapping software (also k... Class II
Jul 27, 2017 iVue with Normative Database, Device Listing Number D185549. Product Usage... FDA determined that a 510(k) is needed for the Vault Mapping software (also k... Class II
Jul 27, 2017 iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... FDA determined that a 510(k) is needed for the Vault Mapping software (also k... Class II
Mar 16, 2016 iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... A software anomaly was detected that affects Optovue iVue and iVue 500 with N... Class II
May 14, 2013 Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... Colors from the NDB comparison for Ganglion Cell Complex thickness in the sin... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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