FDA Adverse Event
Injury
Summary report: N
DUET 19G CURVED ASPIRATION .4MM PORT
MDR report key: 4185992
·
Received October 1, 2014
Report
- Report Number
- 3019924-2014-00042
- Event Type
- Injury
- Date Received
- October 1, 2014
- Manufacturer
- MICROSURGICAL TECHNOLOGY, INC.
- Product Code
- HMX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT THE DEVICE HAD NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
WHILE USING AN MST DUET BI-MANUAL ASPIRATION TIP TO PERFORM THE CAPSULE POLISH PORTION OF A CATARACT SURGERY, THE SURGEON EXPERIENCED A CAPSULE TEAR. NO VITRECTOMY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE PATIENT'S PROGNOSIS WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610093 | DUET 19G CURVED ASPIRATION .4MM PORT | ASPIRATION TIP | HMX | MICROSURGICAL TECHNOLOGY, INC. | DU-02341X1 | 059391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |