MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[188013123]
Device identifiers have been requested. Iop elevation is listed in the device labeling as a potential adverse event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188013124]
The surgeon reports that some of his hydrus microstent patients have had postoperative intraocular pressure (iop) spikes and variable results. Additional information has been requested to understand the number of patients/devices involved and event details.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00007 |
| MDR Report Key | 9742224 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HELENE SPENCER |
| Manufacturer Street | 201 TECHNOLOGY |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6009650130 |
| Manufacturer G1 | IVANITS, INC. |
| Manufacturer Street | 38 DISCOVERY SUITE 150 |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRUS MICROSTENT |
| Generic Name | INTRAOCULAR PRESSURE LOWERING IMPLANT |
| Product Code | OGO |
| Date Received | 2020-02-21 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVANTIS, INC. |
| Manufacturer Address | 201 TECHNOLOGY IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |