FDA Adverse Event
Injury
Summary report: N
HYDRUS MICROSTENT
MDR report key: 11878861
·
Received May 25, 2021
Report
- Report Number
- 3016075957-2021-00019
- Event Type
- Injury
- Date Received
- May 25, 2021
- Report Date
- May 25, 2021
- Manufacturer
- IVANTIS, INC.
- Product Code
- OGO
- UDI-DI
- 00867487000134
- PMA / PMN Number
- P170034
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE HYDRUS MICROSTENTS REMAIN IMPLANTED IN THE PATIENTS AND ARE NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS AND ADDITIONAL PATIENT INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. ELEVATED IOP, MICROSTENT-IRIS TOUCH, AND MICROSTENT OBSTRUCTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2021 THE SURGEON REPORTED THAT HE HAD "A FEW" PATIENTS WHO HAD POSTOPERATIVE INTRAOCULAR PRESSURE (IOP) ELEVATION AND IRIS TISSUE ON THE INLET OF THE HYDRUS MICROSTENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 777321 | HYDRUS MICROSTENT | INTRAOCULAR PRESSURE LOWERING IMPLANT | OGO | IVANTIS, INC. | F00022 | 00867487000134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |