FDA Adverse Event
Injury
Summary report: N
EX-PRESS MINI GLAUCOMA SHUNT
MDR report key: 3935766
·
Received June 23, 2014
Report
- Report Number
- 3003701944-2014-00091
- Event Type
- Injury
- Date Received
- June 23, 2014
- Date of Event
- March 8, 2014
- Report Date
- May 26, 2014
- Manufacturer
- OPTONOL, LTD
- Product Code
- KYF
- PMA / PMN Number
- K030350
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: NO DATA REGARDING PRODUCT IDENTITY WAS REC'D, I.E. NO LOT OR SERIAL NUMBER WERE INDICATED FOR THE EVENT; THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. BECAUSE A SAMPLE WAS NOT RETURNED AND NO LOT NUMBER OR SERIAL NUMBER WERE INDICATED FOR THIS COMPLAINT, THE ROOT CAUSE CANNOT BE DETERMINED. ADD'L INFO HAS BEEN REQUESTED. (B)(4).
Description of Event or Problem · 1
A SURGEON REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE IMPLANT, A PATIENT HAD INCREASED INTRAOCULAR PRESSURE. THE DEVICE WAS FOUND TO BE CLOGGED TEN MONTHS POSTOPERATIVELY. THE DEVICE WAS EXPLANTED. AN IRIDECTOMY AND TRABECULECTOMY WERE ALSO PERFORMED. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364798 | EX-PRESS MINI GLAUCOMA SHUNT | AQUEOUS SHUNT | KYF | OPTONOL, LTD | P-50 PL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention | ALPHAGUN| MITOMYCIN C| COSOPT| LUMIGN |