FDA Adverse Event
Injury
Summary report: N
HYDRUS MICROSTENT
MDR report key: 12027197
·
Received June 18, 2021
Report
- Report Number
- 3016075957-2021-00027
- Event Type
- Injury
- Date Received
- June 18, 2021
- Report Date
- June 18, 2021
- Manufacturer
- IVANTIS, INC.
- Product Code
- OGO
- UDI-DI
- 00867487000134
- PMA / PMN Number
- P170034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MINIMAL INFORMATION WAS PROVIDED, DEVICE IDENTIFIERS AND ADDITIONAL PATIENT INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. MANUFACTURER REFERENCE #: CMP (B)(4).
Description of Event or Problem · 1
SURGEON REPORTS A FEW (1-3) PATIENTS WITH HYDRUS RELATED ISSUES (NONE SPECIFIED) THAT REQUIRE EXPLANTATION. THE PHYSICIAN DID NOT RECALL THE SPECIFICS ABOUT THE PATIENTS, BUT WOULD PROVIDE INFORMATION WHEN HE PERFORMS FOLLOW-UP EXAMINATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922603 | HYDRUS MICROSTENT | INTRAOCULAR PRESSURE LOWERING IMPLANT | OGO | IVANTIS, INC. | F00022 | 00867487000134 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |