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 2020-01-09 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[174529390]
The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings. At this time, the device remains implanted in the patient and has not yet been explanted. Microstent malposition, microstent-iris touch, and microstent explantation are listed in the device labeling as potential adverse events. Manufacturer reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174529391]
A patient underwent cataract surgery with implantation of the hydrus microstent on (b)(6) 2019. On (b)(6) 2019, the surgeon reported that the microstent extended into the anterior chamber and is chafing the iris. The surgeon plans to explant the microstent when a trabeculectomy is performed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00001 |
| MDR Report Key | 9570634 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-09 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Lot Number | 19900318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-09 |