FDA Adverse Event
Malfunction
Summary report: N
EX-PRESS GLAUCOMA FILTRATION DEVICE
MDR report key: 5005188
·
Received August 14, 2015
Report
- Report Number
- 3003701944-2015-00622
- Event Type
- Malfunction
- Date Received
- August 14, 2015
- Report Date
- August 14, 2015
- Manufacturer
- OPTONOL LTD.
- Product Code
- KYF
- PMA / PMN Number
- K012852
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DATA REGARDING PRODUCT IDENTITY WAS RECEIVED I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER OR SERIAL NUMBER WERE INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE AND FAX. A COMPLETED QUESTIONNAIRE WAS NOT RECEIVED. (B)(4).
Description of Event or Problem · 1
A CUSTOMER REPORTED DURING A GLAUCOMA FILTERING DEVICE IMPLANT PROCEDURE, THE SURGEON DISCOVERED THE DEVICE WAS CLOGGED. THE DEVICE WAS NOT IMPLANTED. ANOTHER DEVICE WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 539498 | EX-PRESS GLAUCOMA FILTRATION DEVICE | IMPLANT, EYE VALVE | KYF | OPTONOL LTD. | UNK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |