Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue,
FDA device recall Z-1004-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Optovue Inc.
- Reason for recall
- Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
- Action taken
- Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- NQQ
- Quantity affected
- 22 devices in the US.
- Distribution
- Nationwide
- Date initiated
- 2010-07-20
- Date posted
- 2011-02-01
- Date terminated
- 2011-02-08
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVUE, MODEL 100 (K091404) | Optovue, Inc. | 2010-04-22 |