FDA Adverse Event
Injury
Summary report: N
AHMED GLAUCOMA VALVE
MDR report key: 12028604
·
Received June 18, 2021
Report
- Report Number
- 1000125279-2021-00016
- Event Type
- Injury
- Date Received
- June 18, 2021
- Report Date
- October 13, 2021
- Product Code
- KYF
- PMA / PMN Number
- K162060
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
CUSTOMER PROVIDED LOT NUMBER AND SERIAL NUMBER. THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS REVIEWED, AND PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH NWM PROCEDURES.
Description of Event or Problem · 0
INTRAOCULAR PRESSURE IS NOT GOING DOWN AFTER AN AGV WAS IMPLANTED.
Additional Manufacturer Narrative · 1
THE SAMPLE WAS NOT RETURNED TO NWM; THEREFORE, THE ISSUE REPORTED COULD NOT BE CONFIRMED. THE SERIAL AND LOT#S WERE NOT PROVIDED. IF ADDITIONAL INFORMATION, OR IF THE PRODUCT IS RETURNED TO (B)(6) MEDICAL FOR EVALUATION, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
INTRAOCULAR PRESSURE IS NOT GOING DOWN AFTER AN AGV WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 922307 | AHMED GLAUCOMA VALVE | FP7 | KYF | FP7 | J0720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |