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 2020-01-10 for HYDRUS MICROSTENT F00022 manufactured by Ivantis, Inc..
[188014306]
The device remains implanted in the patient and is not available for evaluation. The device history records were reviewed for this manufacturing lot and there were no discrepancies or unusual findings. The device labeling provides the following instructions: the microstent implantation procedure should be performed after completion of cataract extraction and intraocular lens implantation. It is important to completely remove ovd from inside the bag and from behind the iris before proceeding with hydrus implantation. A high molecular weight cohesive viscoelastic is recommended. Elevated iop is listed in the device labeling as a potential adverse event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188014307]
A patient underwent uneventful cataract surgery with implantation of the hydrus microstent on (b)(6) 2019. On (b)(6) 2019, the surgeon reported that the patient had a fairly high intraocular pressure (iop) spike postoperatively. The following additional information was provided to ivantis on (b)(6) 2020. Preoperatively, the patient's iop in the operative eye was 21 mmhg on one iop-lowering topical medication. One day postoperatively the iop increased to 32 mmhg (unmedicated) and mild corneal edema was noted. On (b)(6) 2019, the patient's iop decreased to 21 mmhg on 3 iop-lowering medications. At this visit the corneal edema had resolved and the patient's best corrected visual acuity (bcva) improved from 20/40 preoperatively to 20/25. The patient's status was listed as stable. At this time, the cause of the iop elevation is unknown. It should be noted that the hydrus microstent was implanted prior to the cataract portion of the procedure, which was performed by a different ophthalmologist (resident); a dispersive viscoelastic was also used. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007683266-2020-00002 |
| MDR Report Key | 9578846 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2020-01-10 |
| 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 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496009650 |
| Manufacturer G1 | IVANITS, INC. |
| Manufacturer Street | 201 TECHNOLOGY |
| Manufacturer City | IRVINE 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 | 2020-01-10 |
| Model Number | F00022 |
| Catalog Number | F00022 |
| Lot Number | 19900083 |
| 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 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-10 |