FDA Adverse Event
Malfunction
Summary report: N
EX-PRESS MINI GLAUCOMA SHUNT
MDR report key: 2040508
·
Received March 18, 2011
Report
- Report Number
- 3003701944-2011-00009
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Report Date
- February 18, 2011
- Manufacturer
- OPTONOL LTD.
- Product Code
- KYF
- PMA / PMN Number
- K030350
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 03/18/2011. (B)(4).
Description of Event or Problem · 1
A SURGICAL TECH REPORTED THE SHUNT WOULD NOT RELEASE FROM THE INJECTOR. SHE REPORTED A BACKUP SHUNT WAS IMPLANTED IN THE SAME PROCEDURE WITH NO IMPACT OR INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EX-PRESS MINI GLAUCOMA SHUNT | AQUEOUS SHUNT | KYF | OPTONOL LTD. | P-50 PL | 102825 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |