Recall Z-1004-2011 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
Optovue Inc.
Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional
| Date | Feb 1, 2011 (initiated Jul 20, 2010) |
| Status | Terminated |
| Reason | Use of the CAM attachment may result in a positioning anomaly and mistreatment in the eyes of the patient. |
| Root cause | Software design (manufacturing process) |
| Action | 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 |
| Quantity | 22 devices in the US. |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091404 | IVUE, MODEL 100 Optovue, Inc., Apr 22, 2010 |