MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-28 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[188632816]
No device identifiers are available and the devices remain implanted in the patients and are not available for evaluation. No additional information is forthcoming. Iritis is listed in the device labeling as a potential adverse event. The postmarket incidence of iritis is significantly below the labeled rate. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188632817]
A surgeon provided the following feedback to ivantis regarding his experience with the hydrus microstent. He reported that his hydrus patients seemed to have more low grade iritis when comparing with other migs procedures and requiring more steroids than usual postoperatively to either calm the iritis or reduce patient discomfort; one patient required a periocular steroid injection. All his patients were managed successfully and have no lingering significant issues. The reporter declined to provide further event details or patient follow-up, so no additional information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00008 |
| MDR Report Key | 9771514 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-28 |
| 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 | 2020-02-28 |
| 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 | 2020-02-28 |