FDA Adverse Event
Malfunction
Summary report: N
EXPRESS MINI GLAUCOMA SHUNT
MDR report key: 4053382
·
Received August 27, 2014
Report
- Report Number
- 3003701944-2014-00139
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- July 16, 2014
- Report Date
- July 31, 2014
- Manufacturer
- OPTONOL LTD.
- Product Code
- KYF
- PMA / PMN Number
- K030350
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE HAS BEEN RECEIVED AND IN-HOUSE EVALUATION IS IN PROGRESS. 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 BUT NOT RECEIVED TO DATE. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED THAT A GLAUCOMA FILTRATION DEVICE COULD NOT BE IMPLANTED SINCE IT DID NOT COME OUT OF THE DELIVERY SYSTEM DURING SURGERY. THE SURGERY WAS COMPLETED USING ANOTHER TECHNIQUE. NO CONSEQUENCES FOR THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522741 | EXPRESS MINI GLAUCOMA SHUNT | AQUEOUS SHUNT | KYF | OPTONOL LTD. | P-50 PL | 141222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |