FDA Adverse Event
Injury
Summary report: N
EX-PRESS MINI GLAUCOMA SHUNT
MDR report key: 2980594
·
Received February 21, 2013
Report
- Report Number
- 3003701944-2013-00013
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 23, 2013
- Manufacturer
- OPTONOL LTD.
- Product Code
- KYF
- PMA / PMN Number
- K030350
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE WAS RETURNED, THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED AND VISUAL INSPECTION COULD NOT BE PERFORMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. (B)(4).
Description of Event or Problem · 1
A NURSE REPORTED THAT FOLLOWING GLAUCOMA FILTERING SURGERY THE SHUNT WAS NOTED TO BE OUT OF POSITION IN THE ANTERIOR CHAMBER. THE SHUNT WAS REMOVED SIX DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, WHO INDICATED THAT THE EVENT RESOLVED WITH TREATMENT. HE ALSO REPORTED THAT IN HIS OPINION THE SHUNT DID NOT CAUSE THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75483 | EX-PRESS MINI GLAUCOMA SHUNT | AQUEOUS SHUNT | KYF | OPTONOL LTD. | P-50 PL | 121324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention | 10.0 NYLON SUTURES| CAUTERY| PREDNISOLONE| OFLOXACIN| 15 BLADE| MITOMYCIN |