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 2020-01-14 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[175075040]
The hydrus microstent was returned to the manufacturer for evaluation; the device investigation findings will be provided in a supplemental report. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings. Microstent explantation is listed in the device labeling as a potential adverse event. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[175075041]
A hydrus microstent was explanted from a patient postoperatively. The date of explant and reason for explant is unknown at this time. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00003 |
| MDR Report Key | 9588801 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-01-14 |
| 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 CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496009650 |
| Manufacturer G1 | IVANITS, INC. |
| Manufacturer Street | 38 DISCOVERY SUITE 150 |
| Manufacturer City | IRVINE, CA CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| 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 | 2020-01-14 |
| Returned To Mfg | 2020-01-03 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Lot Number | 19900233 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IVANTIS, INC. |
| Manufacturer Address | 201 TECHNOLOGY IRVINE, CA CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |